BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBON STEEL SAFETY SCALPEL #21

    MDR report key: 8541702 · Received April 23, 2019

    Report

    Report Number
    9610612-2019-00283
    Event Type
    Injury
    Date Received
    April 23, 2019
    Report Date
    April 23, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    GDX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. 9610612). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION/INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A SCALPEL. DURING AN UNSPECIFIED PROCEDURE, THE SCALPEL DID NOT ENGAGE. THE INCISION WAS THEN LONGER THAN PLANNED. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335354 CARBON STEEL SAFETY SCALPEL #21 BASIC INSTRUMENTS GDX AESCULAP AG BA821SU 4510270165

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention