BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD-PARKER CARBON RIB-BACK BLADES

    MDR report key: 3150198 · Received May 28, 2013

    Report

    Report Number
    1836161-2013-00121
    Event Type
    Malfunction
    Date Received
    May 28, 2013
    Date of Event
    May 19, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THE TIP OF THE BLADE BROKE WHILE DOING THE INCISION ON THE PT. THE BLADE WAS PURCHASED BY (B)(6) AND SOLD TO (B)(6). CONTACT PERSON (B)(6). THE PROCEDURE WAS PERFORMED ON (B)(6) 2013 BY DR (B)(6). THE BLADE WAS TYPICALLY USED FOR THIS PROCEDURE AND HAS NOT BEEN MODIFIED. THE PT WAS NOT BELIEVED TO HAVE BEEN INJURED AS A RESULT OF THIS AND THE PROCEDURE WAS NOT AFFECTED PER CUSTOMER. THEY DID NOT SAVE THE SAMPLE TO RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233120 BARD-PARKER CARBON RIB-BACK BLADES BLADE SIZE 3 15 GES ASPEN SURGICAL PRODUCTS, INC. 371115-150 0027230

    Patients

    Seq Age Sex Outcome Treatment
    1