BEUDAMED
    FDA Adverse Event Summary report: N

    CANE, CRUTCH AND WALKER TIPS AND PADS

    MDR report key: 2231260 · Received September 1, 2011

    Report

    Report Number
    1525712-2011-00484
    Date Received
    September 1, 2011
    Report Date
    September 1, 2011
    Manufacturer
    UNKNOWN
    Product Code
    INP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROLLATOR WAS RETURNED TO THE DEALER AND THE BOLT WAS CHECKED. ACCORDING TO THE DEALER THE BOLT HAD BEEN REMOVED BY THE CONSUMER AND WAS NOT BROKEN. IN ADDITION, THE DEALER ALLEGES THAT THE CONSUMER HAS STATED THAT HE HAS A HISTORY OF REPORTING BROKEN RIBS. THE MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN OF THE CONSUMER WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE MODEL IS ISG1026BLKZ WHICH IS AN INVACARE SUPPLY GROUP DISTRIBUTED PART. THE SERIAL NUMBER IS UNKNOWN. THE LAST KNOWN LOCATION OF THE ROLLATOR WAS WITH THE DEALER. THE DEVICE WAS NEVER FORWARDED TO INVACARE FOR EVALUATION.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THE WHEEL BROKE, CAUSING HIM TO FALL AND FRACTURE HIS RIBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANE, CRUTCH AND WALKER TIPS AND PADS 890.3790 INP UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 Other