BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOWER CHAIR

    MDR report key: 9699 · Received September 5, 1994

    Report

    Report Number
    9699
    Event Type
    Injury
    Date Received
    September 5, 1994
    Date of Event
    August 28, 1994
    Report Date
    September 1, 1994
    Manufacturer
    E F BREWER CO.
    Product Code
    INN
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THIS RESIDENT HAS LEFT-SIDED PARALYSIS SHE WAS SITTING IN SHOWER CHAIR, LEFT ARM FELL DOWN SIDE OF CHAIR. THE RESIDENT PICKED UP HER LEFT ARM USING HER RIGHT HAND. FINGER ON LEFT HAND WAS CUT. THE METAL TUBE FORMING THE ARM REST ENDS UNDER THE CHAIR. THIS METAL TUBE IS OPEN AND NOT SHARP TO THE TOUCH. THERE IS NO OTHER SHARP SURFACE UNDER CHAIR. WENT TO EMERGENCY ROOM FOR STITCHES, HAD SEVERE LACERATION. RESIDENT TO SEE ORTHOPEDIC SURGEON IN 2 WEEKS.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. SERVICE RECORDS NOT AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NO FAILURE DETECTED BUT PRODUCT OUT OF SPECIFICATION. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHOWER CHAIR SHOWER CHAIR INN E F BREWER CO. 16-83500

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention