BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACESETTER II LWR LG WLKR

    MDR report key: 300111 · Received October 13, 2000

    Report

    Report Number
    1624487-2000-00004
    Event Type
    Injury
    Date Received
    October 13, 2000
    Report Date
    October 11, 2000
    Manufacturer
    ELITE ORTHOPEDIC
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ACTUAL PRODUCT NUMBER IS NOT KNOWN. PER THE DISTRIBUTOR, IT COULD HAVE BEEN A SIZE L, OR XL. PT WAS SUPPLIED WITH THE DEVICE BY A HOSP. PT STATES IT CAUSED BLISTERS DUE TO DESIGN. PT STATES THE RIVETS HOLDING THE BUCKLES EXTEND TOO FAR INSIDE THE WALKER. THIS WAS REPORTED TO FACILITY IN 2000, BUT WAS NOT REPORTED TO DEROYAL AT THAT TIME. THE SECOND LETTER TO TETRA IN 2000, FROM THE PT, INDICATES THIS PROBLEM RESULTED IN PARTIAL AMPUTATION OF THE RIGHT FOOT. PT STATES THE BOOT HAD ONLY ONE STRAP WITH ONLY A FEW INCHES OF VELCRO ON IT, AND DID NOT ATTACH PROPERLY TO THE FOAM BOOT AND LEFT FOOT UNPROTECTED AGAINST THE RIVET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACESETTER II LWR LG WLKR CSG SOFTGOODS ITJ ELITE ORTHOPEDIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| O