BEUDAMED
    FDA Adverse Event Injury Summary report: N

    326-1-1 ADULT FRAME LEG EXERCISER

    MDR report key: 3435 · Received July 31, 1992

    Report

    Report Number
    3435
    Event Type
    Injury
    Date Received
    July 31, 1992
    Date of Event
    May 7, 1992
    Report Date
    May 21, 1992
    Manufacturer
    STRYKER SURGICAL
    Product Code
    HRW
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    AT MIDNIGHT, THE START OF THURSDAY, MAY 7, 1992, THE STRYKER SURGICAL ADULT FRAME LEG EXERCISER WAS PLACED UPON THE PATIENT'S LEFT LEG. THE PATIENT WAS OBSERVED DURING NURSING ROUNDS AT 1:00 A.M. WITH NOTHING ABNORMAL NOTICED. AT 2:00 A.M. (DURING NURSING ROUNDS) THE PATIENT WAS FOUND WITH HER FOOT AND ANKLE BETWEEN THE STABLE PART OF THE DEVICE AND THE BARS AND PADDING WHICH MOVE UP AND DOWN. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM AND AN X-RAY OF THE EFFECTED PART TAKEN. THE INCIDENT RESULTED IN A CHIP FRACTURE OF THE LEFT METATARSAL.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. DATE LAST SERVICED: 01-FEB-92. SERVICE PROVIDED BY: DISTRIBUTOR. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. 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
    1 326-1-1 ADULT FRAME LEG EXERCISER N/A HRW STRYKER SURGICAL 326-1-1 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention