BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PGA

    MDR report key: 8755889 · Received July 2, 2019

    Report

    Report Number
    3012164473-2019-00017
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Report Date
    July 2, 2019
    Manufacturer
    CP MEDICAL
    Product Code
    GAM
    UDI-DI
    10790986000657
    PMA / PMN Number
    K002190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    1:3 LOTS ASSOCIATED WITH REPORT - ATTACHMENT: [LOT# 190123-59 RETURN SAMPLE TENSILE TEST.PDF, LOT# 190123-59 RETAIN SAMPLE TENSILE TEST.PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED POLYGLYCOLIC ACID SUTURE BREAKING WHILE TYING KNOTS. (LOT# 190123-59) THE DOCTOR HAS BEEN CONTACTED SEVERAL TIMES AND IS UNWILLING TO PROVIDE DETAILS OF THE EVENTS. THERE IS NO INDICATION OF THE PATIENT EXPERIENCING AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549044 PGA POLYGLYCOLIC ACID ABSORBABLE SYNTHETIC SUTURE GAM CP MEDICAL 494A 190123-59 10790986000657

    Patients

    Seq Age Sex Outcome Treatment
    1