BEUDAMED
    FDA Adverse Event Other Summary report: N

    "SYNTHES" TAP (SEE H10)

    MDR report key: 72951 · Received February 28, 1997

    Report

    Report Number
    1719045-1997-00001
    Event Type
    Other
    Date Received
    February 28, 1997
    Report Date
    February 27, 1997
    Manufacturer
    SYNTHES USA
    Product Code
    HWX
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER AND ITEM NUMBER REPORTED. DEVICE HISTORY RECORD REVIEWED AND NO NON-CONFORMANCE WERE FOUND RELATING TO THIS REPORTED INCIDENT.

    Description of Event or Problem · 1

    TAP BROKE IN PATIENT, PORTION OF TIP REMAINS IN PATIENT. (SEE H10)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 "SYNTHES" TAP (SEE H10) TAP HWX SYNTHES USA NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other