BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERRYWALKER

    MDR report key: 1114 · Received August 18, 1992

    Report

    Report Number
    1114
    Event Type
    Injury
    Date Received
    August 18, 1992
    Date of Event
    May 12, 1992
    Report Date
    May 20, 1992
    Manufacturer
    THE ANTHROS MEDICAL GROUP
    Product Code
    INP
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    RESIDENT WAS IN MERRYWALKER AND WS COMING FROM FOYER INTO LOBBY - GOT STUCK ON THRESHOLD WHICH STICKS UP A BIT, SO HE STOOD UP TO GET OVER IT AND TIPPED OVER BACKWARDSINVALID 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: NONE OR UNKNOWN. CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERRYWALKER INP THE ANTHROS MEDICAL GROUP UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention