BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER III WHEELCHAIR

    MDR report key: 30109 · Received December 19, 1995

    Report

    Report Number
    1417592-1995-09294
    Event Type
    Injury
    Date Received
    December 19, 1995
    Date of Event
    July 6, 1995
    Report Date
    December 19, 1995
    Manufacturer
    EVEREST & JENNINGS, INC.
    Product Code
    INI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    WHEN PT WENT TO SIT IN CHAIR, THE SEAT BROKE. PT WAS TAKEN TO ER. PT SUSTAINED FRACTURED HIP.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASER III WHEELCHAIR WHEELCHAIR INI EVEREST & JENNINGS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention