BEUDAMED
    FDA Adverse Event Other Summary report: N

    GUARDIAN

    MDR report key: 582910 · Received March 21, 2005

    Report

    Report Number
    1034630-2005-00002
    Event Type
    Other
    Date Received
    March 21, 2005
    Date of Event
    January 21, 2005
    Report Date
    March 18, 2005
    Manufacturer
    JAN MAO (MARS PRO)
    Product Code
    FSA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    END-USER CLAIMS THAT THE CLIPS ARE NOT HOLDING PROPERLY. END-USER STATED THAT WHILE TRYING TO TRANSFER FROM THE TRANSFER BENCH TO THEIR WHEELCHAIR THE WHEELCHAIR THE SET CAME OFF. END-USER STATED THAT THEY FELL INTO THE TUB AND SUSTAINED A LUMBAR COMPRESSION FRACTURE ON THEIR LOWER BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN PADDED TRANSFER BENCH FSA JAN MAO (MARS PRO) 98013A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other