BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROBERT WOLF MEDICAL EQUIPMENT

    MDR report key: 110595 · Received July 28, 1997

    Report

    Report Number
    110595
    Event Type
    Injury
    Date Received
    July 28, 1997
    Date of Event
    July 17, 1997
    Report Date
    July 17, 1997
    Manufacturer
    R. WOLF MEDICAL INSTRUMENT CORP.
    Product Code
    HFY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE FINGERS OF THE BANDER DID NOT CLOSE TOGETHER PROPERLY RESULTING IN A TORN FALLOPIAN TUBE, WITH BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROBERT WOLF MEDICAL EQUIPMENT Implant KLIPPINGER BANDER HFY R. WOLF MEDICAL INSTRUMENT CORP. M8383.241 *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention