BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN WALKER DEVICE

    MDR report key: 7526927 · Received May 18, 2018

    Report

    Report Number
    1417592-2018-00038
    Event Type
    Injury
    Date Received
    May 18, 2018
    Date of Event
    November 2, 2017
    Report Date
    May 18, 2018
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE END-USER, A (B)(6) AMPUTEE, FELL WHILE USING A WALKER THAT SHE BELIEVED TO BE MANUFACTURED BY MEDLINE INDUSTRIES, INC. REPORTEDLY, THE END-USER WAS ASCENDING A RAMP INTO HER HOME WHEN THE LEFT-SIDED HAND-HOLD OF THE WALKER "FAILED." REPORTEDLY, "THE LEFT RELEASE RIVET TORE THROUGH THE METAL STAY-BAR." THE END-USER FELL ONTO AN UNIDENTIFIED SIDE AND ONTO AN UNIDENTIFIED SURFACE. IT IS UNKNOWN HOW THE END-USER WAS ABLE TO GET BACK UP AFTER THIS FALL OR IF SHE WENT TO A HOSPITAL, EMERGENCY DEPARTMENT, OR DOCTOR'S OFFICE IMMEDIATELY FOLLOWING THE INCIDENT. AFTER AN UNIDENTIFIED PERIOD OF TIME, THE END-USER WAS REPORTEDLY DIAGNOSED WITH A FRACTURE TO AN UNIDENTIFIED ARM AND WAS REQUIRED TO HAVE SURGERY. NO SPECIFIC DIAGNOSTIC EXAMS WERE REPORTED TO THE MANUFACTURER. THE REPORTED SURGERY WAS NOT IDENTIFIED AND INFORMATION REGARDING THE DATE OF THE SURGERY WAS NOT PROVIDED TO THE MANUFACTURER. NO SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVALID ITEM NUMBER WAS PROVIDED TO THE MANUFACTURER. NO PRODUCT ITEM NUMBER OR LOT NUMBER WAS REPORTED TO INDICATE THE WALKER IS A MEDLINE INDUSTRIES, INC. DEVICE. PHOTOS OF THE WALKER INVOLVED IN THE INCIDENT DID NOT PROVIDE INFORMATION TO CONFIRM IT TO BE A MEDLINE INDUSTRIES, INC. DEVICE. DUE TO THE REPORTED INCIDENT, AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN END-USER FELL WHILE USING A WALKER THAT SHE BELIEVED TO BE MANUFACTURED BY MEDLINE INDUSTRIES, INC. THE END-USER EXPERIENCED A FRACTURE TO AN UNIDENTIFIED ARM WHICH REQUIRED AN UNIDENTIFIED SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369114 UNKNOWN WALKER DEVICE ITJ MEDLINE INDUSTRIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other| R