BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORBABLE SUTURE

    MDR report key: 33426 · Received June 14, 1996

    Report

    Report Number
    MW4001346
    Event Type
    Malfunction
    Date Received
    June 14, 1996
    Report Date
    April 3, 1995
    Manufacturer
    LUKENS CORP.
    Product Code
    GAK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS SUTURE IS NOT OF ADEQUATE QUALITY. THIS SUTURE FRAYS EASILY CAUSING PREMATURE BREAKAGE WHICH IN TURN CAUSES INCISION OPENING. THIS INCREASES THE NEED FOR ADD'L SURGERY TO REPAIR THE INCISION AND INCREASED INCIDENCE OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSORBABLE SUTURE ABSORBABLE SUTURE GAK LUKENS CORP. 0394/014

    Patients

    Seq Age Sex Outcome Treatment
    1 NA