Quality

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Adverse events reporting process

Date:2020-04-10   Click:1564

Thank you for visiting the our website and write email to us to report a serious adverse event, product quality problem, product use/medication error, or therapeutic inequivalence/failure that you suspect is associated with the use of our Personal Protective Equipment (PPE), or other products listed in our website, or sold from our company.

Even there is no certainty that the reported event (adverse event or medication error) was due to the product, but we always believe that your report may be the critical action that prompts a modification in use or design of the product, improves its safety profile and leads to increased patient safety.

After receiving your report, we will have a process in place for reporting adverse events of which they become aware and send such reports to FDA. Here are major process:

 

Whom can send us the AERS?

 

This Regulation establishes the procedure for reporting serious adverse events occurring in using of our products by any people whom used our product, such as people in construction, industry, garden, household, healthcare professionals.

 

2.  Adverse event and adverse reaction

 

(1) An adverse event means any medical occurrence in a health related application and subject administered an investigational medicinal product. An adverse event may be any untoward or unexpected, symptom or disease which has temporal relevance to the use of the investigational medicinal product but which does not necessarily have a causal relationship with this medicinal product.

 

(2) An adverse reaction means an adverse event which may have a causal relationship with the administration of such investigational medicinal product. An adverse reaction of a medicinal product means all untoward and unintended responses to an investigational medicinal product related to any dose administered.

 

(3) A serious adverse event or serious adverse reaction to a medicinal product means any untoward medical occurrence or effect that at any dose:
 1) results in death;
 2) is life-threatening;
 3) results in a need for hospitalization or prolongation of existing hospitalization;
 4) results in prolonged incapacity for work or persistent or significant disability, or
 5) results in a congenital anomaly or birth defect
 6) Other serious adverse you think should be reported to us

 

(4) Unexpected adverse reaction is an adverse reaction the nature, severity or frequency of which is not consistent with the applicable product information. Applicable product information means a summary of the characteristics of the investigational product for an unauthorized product, or a summary of product characteristics or the package leaflet for an authorized product.

 

 

3.  Reporting serious adverse events and adverse reactions occurring in application

 

 (1) Doctors, dentists, veterinarians and users shall report all serious adverse reactions to a medicinal product and adverse events immediately to the sponsor of the clinical trial in writing in a format provided for in the Annex to this Regulation.


 1) suspected unexpected serious adverse reactions that are fatal or life-threatening shall be reported #URGENT PPE# immediately, any case no later than seven calendar days after knowledge by the sponsor or users of such a case;


 2) other suspected unexpected serious adverse reactions which are not fatal or life-threatening shall be reported within fifteen calendar days after knowledge by the sponsor or users of such a case.

 

(5) In a case specified in clause (2) 1), the data which permit the identification of the subjects, information on the medicinal product or medicinal products used, person who submitted the report and adverse reaction shall be indicated in the immediate report. A complete report on such adverse reaction shall be submitted not later than fifteen calendar days after knowledge of such a case.

(6) While writing email to report the AERS, please make sure keep the evidence and other datasheet so that we can check, analyses.

(7) While write reporting, please make sure provide information in Annex (Excel file which is editable).

 

 


4.  Internal Process after receiving the reporting serious adverse events and adverse reactions

 

(1) We will check the email system every day, except holiday and try to monitor the email system to make sure each email will be handled correctly.

(2) After email receiving, we will send an email reply within 72 hours to advise report received. After check all the information in the report, we will analyses, discuss internal, or with suppliers, to find a out a reason why this happened, or maybe would like reporter to give us more details, until we think this evidence was enough for initial analyzing.  

(3) If possible, we will also call the reporter to get more details such as but not limited to: how he used the device/products, anything we can support him to solve current situation, etc.

(4) After all necessary information was received, we will send the report to China CDC, American FDA, immediately and keep communication with them to make sure report was receiving and waiting for further instruction from them.

(5) We will adopt necessary method to find out the reason why this adverse event happened and come up with a solution to correct it, to improve current products.

(6) If there’s evidence that we have to recall the products has the potential issue, we will contact our customers, partners, and also publish news on our website, to make sure necessary action was adopted to prevent issues happen again.

 

If you found out mistake, or improper method was used, or any suggestion to make whole process running more smoothly & efficiently, please also write email to us. It’ll be much appreciated!

Adverse-events-reporting-annex.xlsx



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