BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REAR HOLD DOWN UNIT

    MDR report key: 2762 · Received September 16, 1992

    Report

    Report Number
    2762
    Event Type
    Injury
    Date Received
    September 16, 1992
    Date of Event
    April 14, 1992
    Report Date
    April 27, 1992
    Manufacturer
    CREATIVE CONTROLS, INC.
    Product Code
    KNO
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    WHEELCHAIR RESTRAINT STRAPS LOOSENED DURING VAN TRANSPORT OF PATIENT IN WHEELCHAIR. PATIENT AND WHEELCHAIR TIPPED OVERINVALID 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 USE CONTINUED WITH RESTRICTIONS/LIMITATIONS, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAR HOLD DOWN UNIT KNO CREATIVE CONTROLS, INC. 1202 REAR UNIT

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention