BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE MERRY WALKER

    MDR report key: 468 · Received April 15, 1992

    Report

    Report Number
    468
    Event Type
    Malfunction
    Date Received
    April 15, 1992
    Date of Event
    March 24, 1992
    Report Date
    April 1, 1992
    Manufacturer
    N/A
    Product Code
    INP
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THE MERRY WALKER WAS BEING USED FOR A FEMALE RESIDENT IN ORDER TO AMBUTATE. WHILE AMBUTATING IN HER ROOM SHE TIPPED THE WALKER AND PUNCTURED HER HEAD ON THE CLOSET DOOR OR WALL CORNER. THE RESIDENT WAS ADMINISTERED FIRST AID IN THE FACILITY AND THEN SENT TO THE EMERGENCY ROOM FOR AN EVALUATION. THE MERRY WALKER IS ADVERTISED NOT TO TIP, AND THIS IS NOT THE FIRST TIME THE DEVICE TIPPED OR TOPPLED OVER. THERE WAS NO SERIOUS INJURY SUSTAINEDDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. INVALID DATA - REGARDING 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, OTHER. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE MERRY WALKER N/A INP N/A MW-90 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other