BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENT HEALTH CARE SOLUTIONS

    MDR report key: 1669412 · Received April 23, 2010

    Report

    Report Number
    MW5015697
    Event Type
    Malfunction
    Date Received
    April 23, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 22, 2010
    Manufacturer
    ETHICON - REPROCCESSED BY ASCENT
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE WRAPPING SUTURE AROUND THE OUTER BUTTONS TO SEW THE PACK, ONE OF THE BUTTONS BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENT HEALTH CARE SOLUTIONS HANSON GCJ ETHICON - REPROCCESSED BY ASCENT 836098

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR