BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPASS HEALTH BRANDS

    MDR report key: 20024674 · Received August 22, 2024

    Report

    Report Number
    3012316249-2024-00012
    Event Type
    Injury
    Date Received
    August 22, 2024
    Report Date
    August 23, 2024
    Manufacturer
    OPTIMAL MEDICAL CO., LTD
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    UPDATE: RETURNS EVALUATION: DEVICE SHOWED SIGNS OF USE BUT WAS OVERALL IN GOOD CONDITION EXCEPT FOR BROKEN BACKREST. NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED AT THIS TIME FOR WHY/HOW BACKREST BROKE, BUT IT WAS EVIDENT UPON INSPECTION THAT BACKREST DID BREAK. HANG TAG AND WARNING LABEL ON DEVICE BOTH WARN USER AGAINST LEANING, I.E. BACKREST BAR IS NOT INTENDED TO SUPPORT USER'S WEIGHT. PHOTO BELOW TO SHOW THIS WARNING LABEL WAS STILL PRESENT ON RETURNED DEVICE. TRENDING AND CAPA HISTORY WAS REVIEWED FOR ITEM RLEU10BK-S. CAPA C-001089 WAS ISSUED TO FACTORY ON (B)(6) 2022 TO ADDRESS COMPLAINTS OF NIGHTHAWK BACKRESTS BREAKING. THE DEVICE INVOLVED IN ALLEGED INJURY CASE #(B)(4) WAS MANUFACTURED BEFORE THE CORRECTIVE ACTION IMPLEMENTATION TIED TO (B)(4).

    Description of Event or Problem · 0

    HER MOM BOUGHT A NIGHTHAWK ROLLATOR SHE WAS SITTING ON IT AND IT BROKE AND SHE FELL OUT OF IT AND GOT A CONCUSSION. WANTED TO KNOW WHERE TO BUY A NEW STRAP. SHE WAS PICKED UP BY A NURSE BUT SHE DIDN'T GO TO A HOSPITAL BUT THEY DID SAY SHE HAD A CONCUSSION AND TO WATCH HER FOR 48 HOURS. SHE HAD SOME BLEEDING ON THE BACK OF HER HEAD. SHE DIDN'T SEE IT WHEN IT HAPPENED, SHE WAS SLURRING HER WORDS AFTERWARDS AND SOME BLOOD; THE NURSE TOLD HER WHAT HAPPENED. IT WAS THE STRAP THAT HOLDS YOUR BACK, IT COMPLETELY RIPPED OFF, JUST THE FABRIC SEPARATED FROM THE CLIP. HANG TAG ATTACHED: PAGE 9, CAUTION, 3RD BULLETIN: "DO NOT USE THE BACKREST BAR TO SUPPORT YOUR WEIGHT. LEANING BACK WHILE SEATED ON THE ROLLATOR MAY CAUSE THE DEVICE TO TIP." PAGE 11, 6TH BULLETIN: "DO NOT USE THE BACKREST BAR TO SUPPORT YOUR WEIGHT. LEANING BACK WHILE SEATED ON THE ROLLATOR MAY CAUSE THE DEVICE TO TIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014861 COMPASS HEALTH BRANDS NIGHTHAWK ROLLATOR ITJ OPTIMAL MEDICAL CO., LTD RLEU10BK-S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other