BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPASS HEALTH BRANDS

    MDR report key: 17037292 · Received June 1, 2023

    Report

    Report Number
    3012316249-2023-00016
    Event Type
    Injury
    Date Received
    June 1, 2023
    Date of Event
    October 23, 2019
    Report Date
    June 8, 2023
    Product Code
    IML
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PER CUSTOMER: "I STILL HAVE NOT HEARD ANYTHING FROM YOU FOLKS ABOUT MY WHEELCHAIR INQUIRY. COULD SOMEONE PLEASE LET ME KNOW SOMETHING." CUSTOMER WAS FORWARDED LETTER AGAIN STATING WE CANNOT RESPOND DUE TO LITIGATION. CUSTOMER RESPONDED "SO IF THAT'S THE CASE, I CAN ALWAYS CLAIM THAT YOUR WHEELCHAIR CAUSED THE INJURIES. HOW'S THAT? AND I WON'T BE A CUSTOMER OF YOUR COMPANY AND WILL ENCOURAGE OTHERS TO FIND ALTERNATE SERVICES. HAVE A WONDERFUL DAY."

    Description of Event or Problem · 0

    CALL #1: CUSTOMER WANTS TO TALK TO SOMEONE ABOUT A WHEELCHAIR. STATES HE HAS A ROSCOE WHEELCHAIR, DOESN'T KNOW THE SERIAL NUMBER, BUT WANTS AN EMAIL ADDRESS TO SEND A PICTURE OF THE WHEELCHAIR AND THEN US TELL HIM IF IT'S POSSIBLE FOR A PERSON TO INJURE THEIR UNDER ARM ON THAT WHEELCHAIR. STATES HE HAS INJURIES ON FOREARM, OUTSIDE OF ARM. HE HAD A POLICEMAN GRAB HIS ARM AND CAUSED THEM TO BLEED. HE STATES THE POLICE SAID THE WHEELCHAIR DID IT, HE SAYS POLICE DID IT. HE WANTS DOCUMENTATION STATING THE WHEELCHAIR CANNOT CAUSE THAT TYPE OF INJURY. CALL #2: CUSTOMER STATES BACK IN 2019, HE HAD BEEN THROUGH HEART SURGERY AND HE MADE THE COMMENT HE WAS TEMPTED TO STOP TAKING HIS MEDICATION AND LET NATURE TAKE ITS COURSE. THE PERSON CALLED THE POLICE, THEY GRABBED HIM, GRABBED HIS ARMS WHILE HE WAS IN THE WHEELCHAIR. THE POLICE STATE HE INJURED HIS ARMS ON THE WHEELCHAIR, END USER STATES IT'S NOT POSSIBLE. HE WANTS CHB TO STATE THAT IT'S UNLIKELY FOR A PERSON TO SUFFER THOSE INJURIES IN THE CHAIR. STATES HE HAS A FEDERAL LAWSUIT AGAINST THEM. NOTHING WAS BROKEN, JUST BANDAGED HIS ARMS AND GAVE HIM A TETANUS SHOT. OCCURRED (B)(6) 2019. HE HAS SCARS ON HIS ARMS WHERE THE INJURIES WERE. STATES HE KNOWS THE WHEELCHAIR DID NOT DO IT. REITERATED THAT HE KNOWS THE WHEELCHAIR HAS NOTHING ON IT TO CAUSE THOSE INJURIES. HE STATES HE IS ON BLOOD THINNERS AND HIS SKIN IS BRITTLE ANYWAY AND THEY GRABBED HIM WHICH CAUSED IT. PICTURES PROVIDED: PIC 1 IS OF A RIGHT SIDE VIEW OF A WHEELCHAIR ON A WOODEN RAMP, THE SKIRT GUARD STATES "ROSCOE". PIC 2 IS THE SAME AS PIC 1. PIC 3 IS THE SAME AS PIC 1. PIC 4 SHOWS A RIGHT FOREARM, MANY BLOOD BLISTERS UNDER THE SKIN AND APPROXIMATELY 2" ABOVE WRIST IN CENTER THE SKIN IS TORN OFF IN AN OVAL SHAPE APPROXIMATELY 1" LARGE. PIC 5 SHOWS A RIGHT ARM, MANY BLOOD BLISTERS UNDER THE SKIN AND ONE HAS THE SKIN ORN OFF APPROXIMATELY 1" IN SIZE WITH A LINE GOING INWARD TOWARD BODY APPROXIMATELY 1" IN LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1837171 COMPASS HEALTH BRANDS ARMREST, WHEELCHAIR IML

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other