BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCALPEL HANDEL #3

    MDR report key: 1378 · Received August 18, 1992

    Report

    Report Number
    1417075-1992-00002
    Event Type
    Injury
    Date Received
    August 18, 1992
    Date of Event
    June 17, 1992
    Report Date
    August 11, 1992
    Manufacturer
    SKLAR INSTRUMENTS
    Product Code
    GDZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    NURSE WAS REMOVING A SCALPEL BLADE FROM HANDLE WITH KELLY FORCEPS. FORCEPS SLIPPED AND NURSE'S MID FINGER OF RIGHT WAS CUT. LACERATION REQUIRED 8 STITCHES, A HEPATITIS TITRE AND HIV TITRE AS BLADE WAS CONTAMINATEDDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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. 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: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCALPEL HANDEL #3 SAME GDZ SKLAR INSTRUMENTS UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention