BEUDAMED
    FDA Adverse Event Other Summary report: N

    GUARDIAN FOOTPIECE ATTACHMENT

    MDR report key: 371429 · Received January 15, 2002

    Report

    Report Number
    2020334-2002-00001
    Event Type
    Other
    Date Received
    January 15, 2002
    Date of Event
    December 12, 2001
    Report Date
    January 15, 2002
    Manufacturer
    SUNRISE MEDICAL PCP DIVISION
    Product Code
    INP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END-USER FELL OUT OF BED LANDED ON THE PT'S WALKER THAT WAS NEXT TO THE BED. THE GLIDE BRAKE ON WALKER CUT THE PT'S LEG. STITCHES WERE REQUIRED TO THE PT'S LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN FOOTPIECE ATTACHMENT WALKER ATTACHMENT INP SUNRISE MEDICAL PCP DIVISION 7820 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Other