BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN MEDTRONIC

    MDR report key: 14257487 · Received April 29, 2022

    Report

    Report Number
    MW5109450
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    April 5, 2022
    Report Date
    April 26, 2022
    Manufacturer
    COVIDIEN / MEDTRONIC
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    COVIDIEN MEDTRONIC BIOSYN SUTURE 4-0, P-12. OPENED NEW AND SUTURE NOT ATTACHED TO THE NEEDLE. FDA SAFETY REPORT ID #:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353638 COVIDIEN MEDTRONIC SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM COVIDIEN / MEDTRONIC SM-5627 D1L0648FY

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown