BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC COVIDIEN BIOSYN SUTURE

    MDR report key: 13995559 · Received April 1, 2022

    Report

    Report Number
    MW5108724
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    March 29, 2022
    Report Date
    March 30, 2022
    Manufacturer
    MEDTRONIC / COVIDIEN
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MEDTRONIC BIOSYN 4-0 SUTURE P-12 CUTTING NEEDLE. SUTURE DETACHED WHILE OPENING. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94966 MEDTRONIC COVIDIEN BIOSYN SUTURE SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM MEDTRONIC / COVIDIEN SM-5627 D1K2524FY

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown