BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2142598 · Received June 21, 2011

    Report

    Report Number
    1525712-2011-00280
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 20, 2011
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ALLEGED SERIOUS INJURY. MALFUNCTION ALLEGED. ALLEGEDLY, CONSUMER SUSTAINED INJURY TO HER SHOULDER AND HER KNEE AFTER THE SHOWER CHAIR BROKE INTO. THE CONSUMER HAS BEEN TAKING MEDICATION FOR HER BACK PRIOR TO THE INCIDENT. SHE DID NOT BRUISE BUT IS IN SOME PAIN. SHE ALSO IS DIAGNOSED WITH DIABETES. SHE WAS NOT PRESCRIBED ANY ADDITIONAL MEDICATION. THE CONSUMER DID GO AND SEE HIS DOCTOR. THE PATIENT IS A (B)(6) FEMALE. THE CONSUMER WEIGHTS (B)(6). THE CONSUMER STABILITY IS UNKNOWN. THE SHOWER CHAIR SET UP AND ENVIRONMENTAL CONDITIONS ARE UNKNOWN. MDR FILED FOR MALFUNCTION AND MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    NO ALLEGED SERIOUS INJURY. MALFUNCTION ALLEGED. ALLEGEDLY, CONSUMER SUSTAINED INJURY TO HER SHOULDER AND HER KNEE AFTER THE SHOWER CHAIR BROKE "INTO." THE CONSUMER HAS BEEN TAKING MEDICATION FOR HER BACK PRIOR TO THE INCIDENT. SHE DID NOT BRUISE BUT IS IN SOME PAIN. SHE ALSO IS DIAGNOSED WITH DIABETES. SHE WAS NOT PRESCRIBED ANY ADDITIONAL MEDICATION. THE CONSUMER DID GO AND SEE HIS DOCTOR. THE PATIENT IS A (B)(6) YEAR OLD FEMALE. THE CONSUMER WEIGHS (B)(6) LBS AND IS (B)(6) INCHES TALL. THE CONSUMER'S STABILITY IS UNKNOWN. THE SHOWER CHAIR IS SET UP AND ENVIRONMENTAL CONDITIONS ARE UNKNOWN. MDR FILED FOR MALFUNCTION AND MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    (B)(4) - INVACARE, RECEIVED AN EMAIL FROM SPINLIFE STATING CONSUMER (B)(6) PURCHASED A SHOWER CHAIR MODEL NO. 9781-1. ALLEGEDLY, A NEWLY RECEIVED REPLACEMENT SHOWER CHAIR WAS SAT UPON AND BROKE, CAUSING THE CONSUMER TO FALL ON THE FLOOR OF THE TUB HURTING HER BACK. THE CONSUMER ALLEGES THAT SHE SUSTAINED A BRUISE ON HER ELBOW AND A BUMP ON THE BACK OF HER HEAD. THE CONSUMER STATED SHE WAS SUFFERING FROM A HERNIATED DISC AT THE TIME OF THE ALLEGED INCIDENT. IN ADDITION, THE CONSUMER STATED SHE IS EXPERIENCING A LOT OF PAIN. THE CONSUMER HAS NOT GONE TO THE HOSPITAL FOR EVALUATION.

    Description of Event or Problem · 1

    (B)(4), RECEIVED AN EMAIL FROM (B)(6) STATING CONSUMER (B)(6) PURCHASED A SHOWER CHAIR MODEL NO. 9781-1. ALLEGEDLY, A NEWLY RECEIVED REPLACEMENT SHOWER CHAIR WAS SAT UPON AND BROKE, CAUSING THE CONSUMER TO FALL ON THE FLOOR OF THE TUB HURTING HER BACK. THE CONSUMER ALLEGES THAT SHE SUSTAINED A BRUISE ON HER ELBOW AND A BUMP ON THE BACK OF HER HEAD. THE CONSUMER STATED, SHE WAS SUFFERING FROM A HERNIATED DISC AT THE TIME OF THE ALLEGED INCIDENT. IN ADDITION, THE CONSUMER STATED SHE IS EXPERIENCING A LOT OF PAIN. THE CONSUMER HAS NOT GONE TO THE HOSPITAL...

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention