BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3112770 · Received May 14, 2013

    Report

    Report Number
    1525712-2013-03785
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 18, 2013
    Manufacturer
    UNKNOWN
    Product Code
    INM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MDR DECISION DATE: (B)(4). NO SERIOUS INJURY ALLEGED. OCCUPANT WAS EXITING THE CHAIR AND FORGOT THERE WAS A PULL OUT STEP PRESENT AND EXTENDED. THEY FELL. THIS WAS A VISITOR WHO REPORTS THAT THEY DID THE SAME THING ABOUT 2 WEEKS PRIOR AS REPORTED IN A PREVIOUS COMPLAINT. THEY DID NOT REPORT EARLIER BECAUSE THERE WERE NO INJURIES (THE MENTION REGARDING A BROKEN PELVIS WAS PLACED IN ERROR ON THIS RECORD).

    Description of Event or Problem · 1

    CHAIR OCCUPANT WAS EXITING THE CHAIR AND FORGOT THERE WAS A PULL OUT STEP PRESENT AND EXTENDED. THEY FELL. THIS WAS A VISITOR WHO REPORTS THAT THEY DID THE SAME THING ABOUT 2 WEEKS PRIOR AND DI NOT REPORT BECAUSE THEY WERE NO INJURED. INDIVIDUAL SUSTAINED A BROKEN PELVIS. HE DID NOT REQUIRE SURGERY, BUT DID REQUIRE MORE EXTENSIVE FOLLOW UP CARE. HE WAS DISCHARGED TO A REHAB FACILITY. HE ALSO SUSTAINED A SKIN TEAR ON HIS ELBOW. (B)(6) 2013 - THE ABOVE MENTIONED REGARDING A BROKEN PELVIS WAS PLACED IN ERROR ON THIS RECORD. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213230 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 INM UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 89 Other