BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD-PARKER STAINLESS STEEL BLADE SIZE 11 STERILE

    MDR report key: 19367231 · Received May 21, 2024

    Report

    Report Number
    3002750084-2024-00018
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    March 29, 2024
    Report Date
    May 21, 2024
    Manufacturer
    ASPEN SURGICAL PRODUCTS INC.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM THE FDA MEDWATCH PROGRAM (B)(4) INDICATING THAT A SCALPEL BLADE BROKE WHILE IN USE. THE ACTUAL DEVICE IS BEING RETURNED FOR EVALUATION. THE MANUFACTURING LOT NUMBER WAS PROVIDED. NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    ASPEN SURGICAL RECEIVED A REPORT INDICATING THAT A SCALPEL BLADE BROKE DURING A LEFT SHOULDER ARTHROSCOPY PROCEDURE. ALL PIECES WERE RECOVERED. THERE WAS NO PATIENT INJURY RELATED TO THIS INCIDENT. SAMPLE IS AVAILABLE FOR EVALUATION, AND IS IN PROCESS OF BEING SENT TO ASPEN SURGICAL. NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. LOT INFORMATION WAS PROVIDED. THIS COMPLAINT WAS LOGGED INTO OUR SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583267 BARD-PARKER STAINLESS STEEL BLADE SIZE 11 STERILE SCALPEL BLADE GES ASPEN SURGICAL PRODUCTS INC. 342908

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male