BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINCO

    MDR report key: 1867633 · Received June 9, 2010

    Report

    Report Number
    1027229-2007-00001
    Event Type
    Injury
    Date Received
    June 9, 2010
    Date of Event
    July 8, 2007
    Manufacturer
    WINCO, INC.
    Product Code
    FRJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: ON JULY 26TH WE RECEIVED THE 3500A FORM FROM (B)(6) HOSPITAL HEALTH CENTER. THEY REPORTED THAT A PT RECEIVED AN AMPUTATION OF THE LEFT RING FINGER AT THE DIP JOINT. ON JULY 31ST OUR (B)(4) REP INSPECTED THE SUSPECT CHAIR. HE TOOK PICTURES OF THE CHAIR FROM ALL ANGLES SO THAT WE COULD DIAGNOSE THE POSSIBLE CAUSE OF THE INJURY. HE DISCUSSED WITH THE STAFF HOW THIS EVENT OCCURRED. FROM WHAT THEY COULD DETERMINE, APPARENTLY A (B)(6) PT WAS LOCKED INTO THE FULL RECLINE POSITION; SHE BECAME AGITATED AND TRIED TO GET OUT OF THE CHAIR BY SLIDING FORWARD. SHE THEN PLACED HER LEFT HAND UNDER THE LEFT MECHANISM TO PULL HERSELF FORWARD OUT OF THE CHAIR; WHEN HER WEIGHT WAS SHIFTED OFF THE SEAT TO THE LEGREST/FOOTREST, THE POSITION LOCK BROKE LOOSE AND THE RECLINE MECHANISM FOLDED UP WITH HER FINGER IN A SCISSORS POINT. THE PICTURES REVEALED THAT THE RECLINE MECHANISMS WERE BENT OUTWARD FROM MISUSE; BECAUSE THE MECHANISMS WERE BENT, THE POSITION LOCK DID NOT PROPERLY ENGAGE TO RESTRAIN THE PT INTO THE FULL RECLINE POSITION. A LETTER WAS SENT TO (B)(6) TO ADVISE THEM TO REPLACE THE RECLINE MECHANISMS AND TO CHECK ALL THE OTHER WINCO RECLINERS TO MAKE SURE THEY ARE IN GOOD WORKING CONDITION. CONCLUSION: FACILITY NEEDS TO FOLLOW THE SAFETY/CARE/MAINTENANCE INSTRUCTIONS SUPPLIED WITH THE CHAIR. WINCO ENGINEERING STAFF REVIEWED CURRENT CHAIR TO SEE IF MECHANISM COULD BE SHIELDED; NO IDEAS WERE SUBMITTED. WARNING INSTRUCTIONS ARE CLEAR IN THE OWNER'S MANUAL.

    Description of Event or Problem · 1

    ON THE EVENING SHIFT OF (B)(6) 2007, PT WAS FOUND TO HAVE SUSTAINED AN AMPUTATION AT OR AROUND THE DIP JOINT OF THE LEFT RING FINGER. BLOOD WAS NOTED ON THE RECLINING MECHANISM OF THE CHAIR IN WHICH PT WAS SITTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINCO RECLINER FRJ WINCO, INC. 529

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Disability