BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBON STEEL SCALPEL BLADES #15

    MDR report key: 8511625 · Received April 12, 2019

    Report

    Report Number
    9610612-2019-00269
    Event Type
    Injury
    Date Received
    April 12, 2019
    Date of Event
    March 26, 2019
    Report Date
    April 12, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    GES
    PMA / PMN Number
    EXEMPT
    Adverse Event
    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 THE SCALPEL BLADE. WHILE ATTEMPTING TO INSERT A BLADE ONTO THE HANDLE, THE ASSISTANT CUT HERSELF DEEPLY IN HER THUMB. THE BLADE WAS NOTED TO HAVE "JUMPED" OUT OF THE PACKAGING. IT WAS REPORTED THAT THE ASSISTANT WAS DOING WELL AND IN THE HEALING PROCESS. FURTHER INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304148 CARBON STEEL SCALPEL BLADES #15 BASIC INSTRUMENTS GES AESCULAP AG BB515 4509129959

    Patients

    Seq Age Sex Outcome Treatment
    1 Other HANDLE