BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPEN SURGICAL BLADE

    MDR report key: 14267044 · Received May 2, 2022

    Report

    Report Number
    MW5109474
    Event Type
    Injury
    Date Received
    May 2, 2022
    Date of Event
    March 29, 2022
    Report Date
    April 28, 2022
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CST NOTED THAT THE BLADE ON THE KNIFE HANDLE WAS BROKEN AND WAS MISSING A SMALL PIECE; PIECE COULD NOT BE LOCATED ON THE FIELD OR AROUND THE PATIENT; AN XRAY WAS OBTAINED OF THE SURGICAL SITE AREA AND NO RETAINED FOREIGN BODY WAS NOTED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218648 ASPEN SURGICAL BLADE BLADE, SCALPEL GES ASPEN SURGICAL PRODUCTS, INC. 15 / 113369

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Required Intervention