BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3913

    MDR report key: 3913 · Received May 7, 1993

    Report

    Report Number
    3913
    Event Type
    Injury
    Date Received
    May 7, 1993
    Date of Event
    January 31, 1992
    Manufacturer
    L'NARD ASSOCIATES, INC
    Product Code
    BYN
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    RESIENT WAS SITTING IN WHEELCHAIR WITH A SPECIAL POSTURE DEVICE IN PLACE WHICH IS DESIGNED TO KEEP PERSON STRAIGHT FOR POSTURE PURPOSES. THE DEVICE CONSISTS OF THREE PORTIONS/SIDES WHICH SURROUNDS THE INDIVIDUAL AND THE INDIVIDUAL INSERTS HIS ARMS THROUGH THE DEVIE. A VELCRO STRAP IS USED TO SECURE THE INDIVIDUAL AROUND HIS CHEST. IN THIS INSTANCE, THE STRAP IS USED TO SECURE THE RESIDENT AND THE RESIDENT FELL OUT OF THE WHEELCHAIR AND FRACTURED FEMOR AND HIP. THIS DEVICE HAD BEEN DESIGNED FOR THIS RESIDENT BY THE MANUFACTUREINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, OTHER. RESULTS OF EVALUATION: MODIFICATION OF DEVICE. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. 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 BYN L'NARD ASSOCIATES, INC TLSO

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention