BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROWALKER

    MDR report key: 10842977 · Received November 16, 2020

    Report

    Report Number
    3009481053-2020-00022
    Event Type
    Malfunction
    Date Received
    November 16, 2020
    Date of Event
    October 25, 2020
    Report Date
    November 16, 2020
    Manufacturer
    HANDICARE AB
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP CORRECTION IS BEING ISSUED BECAUSE THE INITIAL REPORT WAS INCORRECTLY SUBMITTED UNDER EXEMPTION #E2015025, WHICH WAS REVOKED EFFECTIVE JUNE 30, 2019. THE REQUEST FOR CORRECTION WAS MADE BY (B)(6), MDR PROGRAM EXPERT AT FDA.

    Description of Event or Problem · 0

    PATIENT WALKED IN THE ROWALKER SUCCESSFULLY. HE WAS TIRED AT THE END OF THE WALK AND WAS SITTING AND RESTING ON THE SEAT. THE THERAPIST HAD HIM "PARKED" CLOSE TO HIS DESTINATION (RECLINER IN ROOM). AS PATIENT WAS SITTING ON THE SEAT OF THE ROWALKER, A LOUD NOISE WAS HEARD AND ONE OF HIS HIPS DROPPED LOWER THAN THE OTHER. THERAPIST AND THE NURSE HAD PATIENT RETURN TO STANDING. THEY LIFTED THE SEAT FLAPS AND INITIALLY THOUGHT THAT ONE OF THESE HAD BROKEN. THE PATIENT WAS ABLE TO STEP OVER TO THE RECLINER WITH THE ASSIST OF 2 PEOPLE AND SAT DOWN IN THE RECLINER. THERAPIST REALIZED THAT THE VERTICAL PORTION OF THE WALKER WAS NO LONGER ATTACHED TO THE BASE ON ONE SIDE, AND SHE REMOVED THE WALKER FROM SERVICE.

    Additional Manufacturer Narrative · 1

    (B)(4), THE IMPORTER, NOTIFIED THE MANUFACTURER, HANDICARE (B)(4), OF THE INCIDENT ON 30OCT2020. THIS UNIT WAS RETURNED TO (B)(4) ON 12NOV2020 AND HAS NOT YET BEEN RETURNED TO HANDICARE AB. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE FINDINGS OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT WALKED IN THE ROWALKER SUCCESSFULLY. HE WAS TIRED AT THE END OF THE WALK AND WAS SITTING AND RESTING ON THE SEAT. THE THERAPIST HAD HIM "PARKED" CLOSE TO HIS DESTINATION (RECLINER IN ROOM). AS PATIENT WAS SITTING ON THE SEAT OF THE ROWALKER, A LOUD NOISE WAS HEARD AND ONE OF HIS HIPS DROPPED LOWER THAN THE OTHER. THERAPIST AND THE NURSE HAD PATIENT RETURN TO STANDING. THEY LIFTED THE SEAT FLAPS AND INITIALLY THOUGHT THAT ONE OF THESE HAD BROKEN. THE PATIENT WAS ABLE TO STEP OVER TO THE RECLINER WITH THE ASSIST OF 2 PEOPLE AND SAT DOWN IN THE RECLINER. THERAPIST REALIZED THAT THE VERTICAL PORTION OF THE WALKER WAS NO LONGER ATTACHED TO THE BASE ON ONE SIDE, AND SHE REMOVED THE WALKER FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314476 ROWALKER WALKER ITJ HANDICARE AB 20101010

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR