BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTJAW 6MM SPRING CLIP

    MDR report key: 20990 · Received February 21, 1995

    Report

    Report Number
    20990
    Event Type
    Injury
    Date Received
    February 21, 1995
    Date of Event
    September 19, 1994
    Report Date
    February 2, 1995
    Manufacturer
    BAXTER
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ON SEPTEMBER 19, 1994 THE SOFTJAW 6MM SPRING CLIP BROKE APART DURING EMERGENCY CORONARY ARTERY BYPASS SURGERY. ALL IDENTIFIED PARTS WERE RETRIEVED IMMEDIATELY. DURING THE EARLY POST-OPERATIVE PERIOD A RETAINED FOREIGN BODY WAS IDENTIFIED AND DETERMINED TO BE THE SPRING PORTION OF THE CLIP. AS A RESULT THIS PATIENT RETAINS THE SPRING PORTION OF THE CLIP WITHIN THE SURGICAL WOUND.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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 SOFTJAW 6MM SPRING CLIP BAXTER

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention