BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN MEDTRONIC BIOSYN SUTURE

    MDR report key: 13976951 · Received March 31, 2022

    Report

    Report Number
    MW5108709
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    March 29, 2022
    Report Date
    March 30, 2022
    Manufacturer
    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 COVIDIEN BIOSYN SUTURE BROKE 3 TIMES. TWICE WHILE TYING AND WHILE HOLDING SUTURE UP TO CUT. THE SURGEON HAD TO RE-SUTURE INCISIONS. THIS WAS FOR A LAPAROSCOPIC CHOLECYSTECTOMY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426217 COVIDIEN MEDTRONIC BIOSYN SUTURE SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM COVIDIEN SM-5637 D1K2074FY

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown