BEUDAMED
    FDA Adverse Event Other Summary report: N

    GUARDIAN

    MDR report key: 320286 · Received March 14, 2001

    Report

    Report Number
    2020334-2001-00006
    Event Type
    Other
    Date Received
    March 14, 2001
    Report Date
    March 14, 2001
    Manufacturer
    SUNRISE MEDICAL/PCP DIVISION
    Product Code
    INN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT END USER WAS SEATED ON CHAIR, WHEN THE LEGS TO ONE SIDE GAVE AWAY, FOLLOWED BY THE LEGS ON THE OTHER SIDE. USER WENT DOWN TO FLOOR. NO INITIAL INJURIES AT TIME OF INCIDENT, POSSIBLE INJURY TO TAIL BONE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11419 GUARDIAN SHOWER CHAIR INN SUNRISE MEDICAL/PCP DIVISION 30400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other