BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSEW

    MDR report key: 5011103 · Received August 13, 2015

    Report

    Report Number
    MW5055459
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 27, 2015
    Report Date
    August 4, 2015
    Manufacturer
    DEPUY/MITEK INC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TIP OF THE DEPUY EXPRESSEW BROKE OF IN THE PATIENT'S SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532687 EXPRESSEW EXPRESSEW SUTURE NEEDLE LXH DEPUY/MITEK INC 23423

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR