BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEX S GR 1X12 LE140-9 7/0 DANS

    MDR report key: 408350 · Received July 29, 2002

    Report

    Report Number
    2648188-2002-00075
    Event Type
    Malfunction
    Date Received
    July 29, 2002
    Date of Event
    May 22, 2002
    Report Date
    May 31, 2002
    Manufacturer
    MANATI - USS
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY THE SUTURE BROKE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEX S GR 1X12 LE140-9 7/0 DANS ABSORBABLE SYNTHETIC SUTURE GAM MANATI - USS * 974642G

    Patients

    Seq Age Sex Outcome Treatment
    1 *