BEUDAMED
    FDA Adverse Event Summary report: N

    COVIDIEN 2-0 SOFSILK GS-62-M

    MDR report key: 15595957 · Received October 12, 2022

    Report

    Report Number
    MW5112589
    Date Received
    October 12, 2022
    Date of Event
    September 29, 2022
    Report Date
    October 8, 2022
    Manufacturer
    COVIDIEN
    Product Code
    GAP
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    COVIDIEN 2-0 SOFSILK GS-62-M, (LOT #: D2A0638Y/EXPIRATION: 2026-12-31), NEEDLES BROKE DURING SURGICAL PROCEDURE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2176939 COVIDIEN 2-0 SOFSILK GS-62-M SUTURE, NONABSORBABLE, SILK GAP COVIDIEN D2A0638Y

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female