BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE

    MDR report key: 17610433 · Received August 24, 2023

    Report

    Report Number
    17610433
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Date of Event
    May 25, 2023
    Report Date
    May 30, 2023
    Manufacturer
    ETHICON, LLC
    Product Code
    GAW
    UDI-DI
    10705031018587
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PROLENE 5-0 BV-1 HAD A HAIR WRAPPED AROUND PROLENE SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302000 PROLENE SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON, LLC 8661G SCBCLS 10705031018587

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown