BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDO-SURGERY, INC.

    MDR report key: 309168 · Received December 15, 2000

    Report

    Report Number
    MW1020633
    Event Type
    Injury
    Date Received
    December 15, 2000
    Date of Event
    December 7, 2000
    Report Date
    December 15, 2000
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING STAPLING OF LACERATION, THE ROTATING HEAD SKIN STAPLER BROKE AT HANDLE AREA AND REMAINING DEVICE WAS ATTACHED TO PT'S HEAD. PHYSICIAN ANESTHETIZED THE AREA AND REMOVED STAPLER. LACERATION WAS THEN REPAIRED WITH ANOTHER SIMILAR DEVICE WITH NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, INC. ROTATING HEAD SKIN STAPLER -35 REGULAR- GDT ETHICON ENDO-SURGERY, INC. 35 REGULAR -PRR35- N4HY3D

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention