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13MED050679 059701 K30924 06/06/2014TABLE OF CONTENTS ARTICLE IA. Recognition ............ ... .. . . . ..... .... .. . . ...... .. . . . . . . . . . ... ... ............ ... .. .... .. . ... B. Board
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13-med-05-0679 is a form used for reporting medical device adverse events.
Manufacturers, importers, and device user facilities are required to file 13-med-05-0679.
13-med-05-0679 must be filled out with details of the medical device adverse event, including information about the patient, the device, and the adverse event itself.
The purpose of 13-med-05-0679 is to monitor and track adverse events related to medical devices for patient safety.
Information such as the patient's age, gender, event description, device information, and contact information must be reported on 13-med-05-0679.
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