BEUDAMED
    FDA Adverse Event Other Summary report: N

    GOLDEN COMPANION GC221

    MDR report key: 1770350 · Received July 21, 2010

    Report

    Report Number
    2523955-2010-00003
    Event Type
    Other
    Date Received
    July 21, 2010
    Date of Event
    March 19, 2010
    Report Date
    July 19, 2010
    Manufacturer
    GOLDEN TECHNOLOGIES
    Product Code
    INI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS APPEARS TO BE AN ACCIDENT/FALL CAUSED BY THE USER REACHING FOR THE GATE BEYOND THE TIPPING POINT OF THE 3-WHEELED SCOOTER. THE USER HAD THE SCOOTER FOR MORE THAN 2 YEARS BEFORE THE ACCIDENT WITHOUT ANY SIMILAR INCIDENTS. NO OTHER CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    END USER'S SPOUSE STATED THAT HER HUSBAND RARELY WENT OUTSIDE BUT DID ON FRIDAY AFTERNOON (B)(6) 2010. SHE SAID THAT HE WENT TO SEE A PUPPY NEXT DOOR ON HIS SCOOTER. WHEN RETURNING HOME, HE REACHED OVER TO CLOSE THE GATE WHILE ON HIS SCOOTER AND FELL OFF. THE SCOOTER ROLLED OVER ONTO HIM. SOMEONE PICKED HIM UP AND HE ONLY RECEIVED A SCRATCH ON THE ARM. ON SUNDAY (B)(6) 2010, PT COMPLAINED TO NURSE THAT HIS STOMACH STARTED HURTING WHILE SHE WAS DRESSING HIS CUT. THE FOLLOWING WEDNESDAY WITH THE PT STILL COMPLAINING OF STOMACH ACHE, THE SON TOOK HIM TO THE EMERGENCY ROOM WHERE THEY PUT A TUBE INTO HIS BOWELS. THE FOLLOWING TUESDAY, HE HAD SURGERY FOR A BOWEL OBSTRUCTION KINK. HE THEN GOT PNEUMONIA AND DIED ON FRIDAY MORNING. THE DOCTOR ASKED IF HE HAD A FALL BECAUSE THERE WAS ALSO BLOOD IN THE BOWEL AND ACCORDING TO THE PT'S WIFE, THE DOCTOR CLAIMED TRAUMA FROM WHEELCHAIR FALL ON THE DEATH CERTIFICATE. PT HAD PRE-EXISTING MYELOMA CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLDEN COMPANION GC221 SCOOTER 3 WHEEL INI GOLDEN TECHNOLOGIES GC221

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death