BEUDAMED
    FDA Adverse Event Summary report: N

    CMC II COAGULATOR (80-1140)

    MDR report key: 4466 · Received August 20, 1992

    Report

    Report Number
    4466
    Date Received
    August 20, 1992
    Manufacturer
    CODMAN & SHURTLEFF INC.
    Product Code
    FEH
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT SUSTAINED A LIP BURN DURING TONSILLECTOMY.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 CMC II COAGULATOR (80-1140) FEH CODMAN & SHURTLEFF INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Invalid Data