BEUDAMED
    FDA Adverse Event Summary report: N

    ANTHROS

    MDR report key: 117348 · Received August 26, 1997

    Report

    Report Number
    1932356-1997-00004
    Date Received
    August 26, 1997
    Date of Event
    August 7, 1997
    Manufacturer
    THE ANTHROS MEDICAL GROUP
    Product Code
    INN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PRODUCT EXTRA WIDE SHOWER CHAIR. THE CHAIRS RIGHT FRONT LOWER LEG FITTING CRACKED ON THE BACK SIDE. THE SAFETY RING DID PERFORM AS DESIGNED. THE CHAIR SHOWS SOME ABUSE ON THE FRONT OF THE UNIT AS IF BEING PUSHED INTO A WALL OR LEDGE. THE CRACK COULD ALSO HAVE BEEN CAUSED BY PUSHING THE CAHIR OVER THE THRESHOLD OF A DOOR. THIS PUTS EXTRA STRESS ON THE FITTINGS. THE CHAIR IS DESIGNED TO BE USED ON LEVEL SURFACES ONLY.

    Description of Event or Problem · 1

    NA/R WAS PULLING SHOWER CHAIR WITH RESIDENT SITTING ON IT-OUT SHOWER ROOM INTO ALCOVE AND HALLWAY. SHE WAS TURNING SHOWER CHAIR AROUND TO GO FORWARD, SHE HEARD A CREAKING NOISE AND THE RIGHT FRONT WHEEL POPPED OFF THE CHAIR. RESIDENT FELL FORWARD, HITTING HEAD AND RIGHT SHOULDER ON THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTHROS SHOWER CHAIR INN THE ANTHROS MEDICAL GROUP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR