BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2617249 · Received June 15, 2012

    Report

    Report Number
    1531186-2012-00390
    Date Received
    June 15, 2012
    Report Date
    June 12, 2012
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONSUMER'S WIFE CALLED AND STATED THAT THE 9781 SHOWER CHAIR SEAT HAS CRACKED, EAST TO WEST IN MULTIPLE SPOTS. THE CONSUMER CAUGHT HIMSELF TO PREVENT A FALL. THE CONSUMER RECEIVED THE SHOWER CHAIR FROM A LOCAL HOSPITAL. NO RMA ISSUED AT THIS TIME. NO INJURY.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED SEAT HAD MULTIPLE CRACKS WITH THE BIGGEST CRACK GOING ACROSS THE SEAT (EAST AND WEST DIRECTION). NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES 890.5050 ITJ UNKNOWN 9781

    Patients

    Seq Age Sex Outcome Treatment
    1 Other