BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN

    MDR report key: 8188 · Received August 11, 1993

    Report

    Report Number
    8188
    Event Type
    Malfunction
    Date Received
    August 11, 1993
    Date of Event
    February 28, 1993
    Manufacturer
    GUARDIAN PRODUCTS CO., INC.
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    RESIDENT WAS USING HER FRONT WHEELED WALKER WHICH HAS A PLATFORM CRUTCH ATTACHMENT. THE BOLTS THAT HOLD THE PLATFORM CRUTCH ATTACHMENT ON THE WALKER BROKE, THUS CAUSING THE RESIDENT TO FALL. THE RESIDENT SUSTAINED NO INJURIES. THE BOLTS WERE REPLACED. THE DEVICE WAS PUT BACK INTO USE.DEVICE NOT LABELED FOR SINGLE USE. 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: COMPONENT FAILURE. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN PLATFORM CRUTH ATTACHMENT GUARDIAN PRODUCTS CO., INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Other