BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYSORB

    MDR report key: 11515179 · Received March 18, 2021

    Report

    Report Number
    11515179
    Event Type
    Malfunction
    Date Received
    March 18, 2021
    Date of Event
    March 8, 2021
    Report Date
    March 12, 2021
    Manufacturer
    COVIDIEN LP
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COVIDIEN LP POLYSORB SUTURES POPPING OFF NEEDLES DURING OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413565 POLYSORB SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM COVIDIEN LP J0H1555Y

    Patients

    Seq Age Sex Outcome Treatment
    1 8760 DA