BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 1659875 · Received January 19, 2010

    Report

    Report Number
    1659875
    Event Type
    Injury
    Date Received
    January 19, 2010
    Date of Event
    December 14, 2008
    Report Date
    January 18, 2010
    Manufacturer
    UNK
    Product Code
    IOE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS IN A WHEELCHAIR AND WHEELED HERSELF UP TO A SET OF PARALLEL BARS WITH A THRESHOLD. WHEN THE WHEELCHAIR ROLLED OVER THE THRESHOLD, THE WHEELCHAIR TIPPED BACK RESULTING IN A HEAD INJURY THAT REQUIRED SURGERY. THE EVENT OCCURRED ON (B)(6) 2008. A LETTER DATED (B)(6) WAS REC'D ALLEGING EQUIPMENT CONTRIBUTED TO THE INJURY. INVESTIGATION PENDING. THIS ORIGINAL REPORT WAS SUBMITTED ON (B)(6) 2009 AS A VOLUNTARY REPORTING USING FORM FDA 3500 INSTEAD OF FORM FDA 3500A. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PARALLEL BARS IOE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention