BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPERSTAND

    MDR report key: 2949526 · Received February 4, 2013

    Report

    Report Number
    3007494904-2013-00001
    Event Type
    Other
    Date Received
    February 4, 2013
    Date of Event
    November 22, 2012
    Report Date
    February 4, 2013
    Manufacturer
    THE STANDING COMPANY
    Product Code
    IPL
    PMA / PMN Number
    K032101
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER HAS REVIEWED SAFE OPERATING PROCEDURES (SOPS) WITH CUSTOMER AGAIN. CUSTOMER ACKNOWLEDGES HIS WHEELCHAIR WAS NOT DOWN TOTALLY IN THE FAIL-SAFE POSITION. MANUFACTURER UPDATED THE SAFE OPERATING PROCEDURES ON 12/13/2012. (S.O.P.) RULE #1, NOW READS: BEFORE TRANSFERRING IN OR OUT OF THE CHAIR OR BEFORE BENDING OVER TO REACH THE FLOOR...I MUST MAKE SURE THE SAFETY LOCK IS ON (THAT IS, CHAIR IS IN FULL DOWN POSITION - WITH RAISE LEVERS ALL THE WAY TO THE REAR). (S.O.P) RULE #17, I UNDERSTAND SUPERSTAND MUST BE COMPLETELY DOWN BEFORE TRANSFERRING OUT. (LISTEN FOR CLICK AND CLUNK WHEN RAISE LEVERS GO ALL THE WAY TO THE REAR).

    Description of Event or Problem · 1

    THE CUSTOMER CALLED IN ON (B)(6) 2012 AND SAID HE FELL OUT OF HIS WHEELCHAIR AROUND (B)(6). CUSTOMER HAD BEEN USING THE STAND UP WHEELCHAIR SINCE (B)(6) 2012 (3 MONTHS). CUSTOMER SAID HE LEANED OVER TO PICK UP KEYS OFF THE FLOOR AND FELL OUT OF HIS CHAIR WHEN THE WHEELCHAIR ROSE UP AS HE SHIFTED HIS WEIGHT OFF THE SEAT BECAUSE HE DIDN'T BRING IT DOWN TO THE LOCKED POSITION. CUSTOMER GOT BACK IN THE CHAIR AND CONTINUED WITH HIS DAY. HE DID NOT THINK IT WAS A BIG DEAL. CUSTOMER DID NOT SEEK MEDICAL CARE NOR SEE A DOCTOR UNTIL TWO WEEKS LATER. THE DOCTOR IDENTIFIED A FRACTURE OF THE LEG AND ADVISED CUSTOMER TO STAY OFF HIS LEG FOR A MONTH OR SO UNTIL IT HEALED. THE CUSTOMER NOTIFIED THE STANDING COMPANY ON (B)(6) 2013 THAT HIS LEG HAS NOT HEALED PROPERLY AND THAT FURTHER MEDICAL ATTENTION MAY BE NECESSARY. WE ARE CURRENTLY AWAITING FOR ANY MEDICAL UPDATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46814 SUPERSTAND STAND UP WHEELCHAIR IPL THE STANDING COMPANY HPS-2

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other