BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANE, CRUTCH AND WALKER TIPS AND PADS

    MDR report key: 2170545 · Received July 21, 2011

    Report

    Report Number
    1525712-2011-00347
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 17, 2011
    Report Date
    July 13, 2011
    Manufacturer
    CONSMA
    Product Code
    INP
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER KNOWINGLY USED A DEVICE WITH A BROKEN SEAT FOR A WEEK WHEN THE ALLEGED INCIDENT OCCURRED.

    Description of Event or Problem · 1

    THE CONSUMER SAT DOWN ON THE ROLLATOR WHEN THE METAL TUBING THAT SUPPORTS THE SEAT IN THE REAR ALLEGEDLY "GAVE WAY", CAUSING THE WELDS ON THE RIGHT REAR TUBING TO BREAK LOOSE. THE CONSUMER CONTINUED TO USE THE ROLLATOR AND TRIED TO SIT CLOSER TO THE SIDE THAT WAS NOT BROKEN. ONE WEEK LATER THE CONSUMER SAT DOWN AND SEAT ALLEGEDLY "GAVE OUT" COMPLETELY, CAUSING HIM TO STUMBLE, BUT NOT FALL. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANE, CRUTCH AND WALKER TIPS AND PADS 890.3790 INP CONSMA 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 54