BEUDAMED
    FDA Adverse Event Other Summary report: N

    WHEELCHAIR, BARIATRIC, 28", REM D

    MDR report key: 1121268 · Received August 15, 2008

    Report

    Report Number
    1417592-2008-00024
    Event Type
    Other
    Date Received
    August 15, 2008
    Report Date
    August 11, 2008
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    IOR
    Removal / Correction Number
    1417592-3/19/08-0001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STAFF MEMBER WAS OPENING THE CHAIR AND HAD HER FINGER PINCHED BETWEEN THE SEAT TUBE AND THE FRAME. IT WAS REPORTED THAT IN THE PROCESS, IT TOOK OFF A "CHUNK" OF THE FINGER. NO FRACTURE RESULTED. THE END USER HAD SURGERY TO REPAIR IT. NO OTHER DETAILS WERE PROVIDED RELATED TO THE INCIDENT, THE EXTENT OF THE INJURIES OR THE CURRENT CONDITION OF THE EMPLOYEE. THE FACILITY WOULD NOT RELEASE THE CHAIR FOR EVALUATION. A FIELD CORRECTIVE ACTION INITIATED ON 3/19/2008. CUSTOMER WAS SENT NEW SEAT UPHOLSTERY, CAUTION LABELS AND INSTRUCTIONS DESCRIBING HOW TO OPEN THE WHEELCHAIR. A REMEDIAL ACTION EXEMPTION WAS FILED, WHICH IS WHY THE MEDWATCH REPORT WAS NOT SUBMITTED AT THAT TIME. WE LATER RECEIVED A CALL FROM THE REMEDIAL ACTION EXEMPTION OFFICE OF THE FDA. SHE STATED THE NUMBER OF OUR ADVERSE EVENTS WERE SO SMALL FOR THIS DEVICE THAT WE DID NOT QUALIFY FOR A REMEDIAL ACTION EXEMPTION. SHE STATED WE WOULD BE SENT A FORMAL WRITTEN NOTIFICATION OF THE DETERMINATION AND THAT FUTURE INCIDENTS MUST BE RECORDED UNDER THE MEDWATCH PROGRAM. AS OF THIS DATE, WE HAVE NOT RECEIVED A LETTER DENYING OUR EXEMPTION REQUEST. ALL MDR REPORTABLE INCIDENTS FOR THIS DEVICE WHICH OCCURRED AFTER OFFICE PHONE CALL HAVE BEEN FILED WITHIN THE REQUIRED TIMEFRAME. THIS MED WATCH REPORT IS BEING FILED FOR THIS INCIDENT IN RESPONSE TO A LETTER WE RECEIVED. THE FIELD REWORK WAS INITIATED AND COMPLETED AT THIS FACILITY. AS A RESULT, NO FURTHER CORRECTIVE ACTION IS INDICATED.

    Description of Event or Problem · 1

    A STAFF MEMBER WAS OPENING THE WHEELCHAIR. HER FINGER WAS INJURED AS IT WAS CAUGHT BETWEEN THE SEAT TUBE AND THE FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHEELCHAIR, BARIATRIC, 28", REM D NONE IOR MEDLINE INDUSTRIES, INC. MDS809850

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other