BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN

    MDR report key: 15612098 · Received October 14, 2022

    Report

    Report Number
    15612098
    Event Type
    Malfunction
    Date Received
    October 14, 2022
    Date of Event
    September 19, 2022
    Report Date
    September 27, 2022
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    IPR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT GIVEN A PAIR OF CRUTCHES FROM CENTRAL SUPPLY AND PHYSICAL THERAPIST PROVIDED CRUTCH TRAINING IN HALLWAY WHEN PATIENT'S CRUTCH SUDDENLY COLLAPSED REQUIRING PHYSICAL THERAPIST ASSIST TO MAINTAIN NON WEIGHT BEARING (NWB) AND BALANCE THEN ASSISTED INTO CHAIR. ALL OTHER SETS OF CRUTCHES WITH SAME LOT HAVE BEEN PULLED FROM STOCK TO RETURN TO MANUFACTURING REP FOR REPLACEMENT. MANUFACTURER RESPONSE FOR CRUTCHES, GUARDIAN (PER SITE REPORTER). THEY WILL BE COMING BY TO PICK THEM UP AND ARE WORKING TO REPLACE THE OTHER ITEMS WITH SAME LOT #.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2820411 GUARDIAN CRUTCH IPR MEDLINE INDUSTRIES LP MDSV80534 88522010001

    Patients

    Seq Age Sex Outcome Treatment
    1 6935 DA Male