BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEANEY

    MDR report key: 598131 · Received April 27, 2005

    Report

    Report Number
    598131
    Event Type
    Injury
    Date Received
    April 27, 2005
    Date of Event
    April 8, 2005
    Report Date
    April 27, 2005
    Manufacturer
    CODMAN AND SHURTLEFF, INC.
    Product Code
    HCZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY THE CLAMP TIP BROKE IN THE PATIENT. THE TIP WAS FOUND AND RETRIEVED WITH THE HELP OF X-RAY. THIS EXTENDED THE LENGTH OF SURGERY. AFTER SURGERY, IT WAS NOTED THAT ALL OF THE CLAMP HAD NOT BEEN RETRIEVED. X-RAY TAKEN SHOWED SMALL TOOTH OF CLAMP STILL IN PATIENT. THE PATIENT WAS OFFERED SURGERY TO REMOVE THE METAL BUT THE PATIENT OPTED TO LEAVE THE SMALL PIECE OF METAL IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEANEY HYSTERECTOMY FORCEPS HCZ CODMAN AND SHURTLEFF, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R NO OTHER THERAPIES