BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2143199 · Received June 28, 2011

    Report

    Report Number
    1525712-2011-00307
    Date Received
    June 28, 2011
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALLEGED INJURY WITH NO DETAILS. NO MALFUNCTION ALLEGED. THE DEALER RECEIVED A SUBPOENA FOR INFORMATION RELATED TO A TRANSFER BENCH THAT WAS SUPPLIED BY THEM TO A CONSUMER. THE DEALER THOUGHT THIS COULD BE RELATED TO AN ALLEGED INJURY, BUT DID NOT HAVE ANY SPECIFIC INFORMATION. THE DEALER DOES NOT HAVE THE CONSUMER LISTED AS A PATIENT. THE CONSUMER WALKED IN AND PURCHASED PRODUCT WITH CASH/ NO PRESCRIPTION. THE DEALER BELIEVES THAT THE CONSUMER WAS A VISITOR IN (B)(6). CONSUMER RESIDES IN (B)(6). THE TRANSFER BENCH WAS PURCHASED UNDER THE CONSUMERS' NAME, BUT THE DEALER CANNOT CONFIRM THAT IT WAS FOR HER. THE MODEL NUMBER WAS NOT LISTED, BUT THE DEALER BELIEVES THAT IT IS THE MODEL NUMBER 98071 AS THIS IS THE ONLY MODEL THAT HE SELLS. THE DEALER DOES NOT HAVE A PHONE NUMBER LISTED IN (B)(6). THE DEALER DID NOT KNOW THE EXTENT OF THE INJURY OR IF THE CONSUMER RECEIVED MEDICAL ATTENTION. THE AGE, HEIGHT AND WEIGHT WERE NOT RECORDED AT THE TIME OF THE PURCHASE. THE ENVIRONMENTAL CONDITIONS FOR THE TRANSFER BENCH ARE UNKNOWN. THE MAINTENANCE AND CONDITION ARE UNKNOWN. THE PRODUCT IS NOT BEING RETURNED AS THE DEALER IS UNAWARE OF THE LOCATION OF THE UNIT. THE EXTENT OF THE ALLEGED INJURY IS UNKNOWN. MDR FILED BASED ON ALLEGED INJURY WITH NO DETAILS.

    Description of Event or Problem · 1

    THE DEALER RECEIVED A SUBPOENA FOR INFORMATION RELATED TO A TRANSFER BENCH THAT WAS SUPPLIED BY THEM TO A CONSUMER. THE DEALER THOUGHT THIS COULD BE RELATED TO AN ALLEGED INJURY, BUT DID NOT HAVE ANY SPECIFIC INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1