BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEZE

    MDR report key: 35058 · Received June 25, 1996

    Report

    Report Number
    35058
    Event Type
    Injury
    Date Received
    June 25, 1996
    Date of Event
    June 15, 1996
    Report Date
    June 20, 1996
    Manufacturer
    CHICK MEDICAL PRODUCTS
    Product Code
    ILZ
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    TRAPEZE DEVICE BROKE AND FELL ON PT'S HEAD. NO LOSS OF CONSCIOUSNESS, NO FRACTURE. SCALP LACERATION REQUIRING SUTURES. MILD SWELLING AND ERYTHEMA UNDER LEFT EYE. PT WAS POSTOPERATIVE RIGHT HIP FRACTURE. METAL EQUIPMENT ATTACHED PROPERLY. IT BROKE IN TWO. DIALOGUE WITH MFR TAKING PLACE TO ASCERTAIN CONDITION OF OTHER 18 DEVICES. IDENTIFICATION OF PURCHASE DATE IN PROCESS WITH MFG. PART OF DEVICE RETURNED TO MFR.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: OTHER. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZE TRAPEZE ILZ CHICK MEDICAL PRODUCTS DK DK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention