BEUDAMED
    FDA Adverse Event Other Summary report: N

    WHEELCHAIR,BARIATRIC,26",REM F

    MDR report key: 1700030 · Received May 25, 2010

    Report

    Report Number
    1417592-2010-00030
    Event Type
    Other
    Date Received
    May 25, 2010
    Report Date
    May 18, 2010
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STAFF MEMBER WAS OPENING THE CHAIR AND HAD HER FINGERS WRAPPED AROUND THE SEAT TUBE. AS IT OPENED, HER FINGER WAS CAUGHT AND SHE SUFFERED A FRACTURE. THE INCIDENT OCCURRED SOME TIME IN (B)(6) BUT WAS NOT REPORTED UNTIL NOW. THE SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. NO LOT NUMBER PROVIDED. THE FACILITY REPORTED THAT THEY HAVE 7-10 SIMILAR WHEELCHAIRS AND THEY DO NOT KNOW WHICH ONE WAS INVOLVED IN THE INCIDENT. THE FACILITY REPORTS, THE INCIDENT WAS THE RESULT OF A LACK OF KNOWLEDGE ON THE PART OF THE STAFF MEMBER. THEY PLAN TO CONDUCT INSERVICE TRAINING FOR THE STAFF REGARDING THE CORRECT WAY TO OPEN A WHEELCHAIR. THEY STATED, THE INCIDENT RESULTED FROM A LACK OF APPROPRIATE TRAINING AND DUE TO THE STAFF MEMBER BEING RUSHED. THEY USE THESE CHAIRS THROUGHOUT THE FACILITY AND DO NOT HAVE SIMILAR ISSUES. NO REMEDIAL ACTION IS INDICATED AT THIS TIME. THIS MEDWATCH IS BEING FILED DUE TO THE REPORTED INJURY.

    Description of Event or Problem · 1

    WHEN OPENING THE CHAIR, A STAFF MEMBER WRAPPED HER FINGERS AROUND THE SEAT TUBES. AS THE CHAIR FULLY OPENED, SHE FRACTURED A FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHEELCHAIR,BARIATRIC,26",REM F NONE IOR MEDLINE INDUSTRIES, INC. MDS809750 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention