BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATGUT CHROMIC 2/0 (3.5) 100M

    MDR report key: 8108333 · Received November 27, 2018

    Report

    Report Number
    3003639970-2018-00752
    Event Type
    Malfunction
    Date Received
    November 27, 2018
    Report Date
    November 27, 2018
    Manufacturer
    B. BRAUN SURGICAL SA
    Product Code
    GAL
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER, REGISTRATION NO. 3003639970). EXEMPTION NUMBER: E2014012. REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, (B)(4) MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. EVENT DATE: UNKNOWN. 510 K: K991223. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. THERE ARE NO UNITS IN THE WAREHOUSE. AN OPEN AND USED CASSETTE WAS RECEIVED. THREAD ON THE SAMPLE RECEIVED IS BROKEN INSIDE THE CASSETTE. THREAD WAS PROBABLY TANGLED IN THE REEL AND WHEN PULLING OUT THE THREAD, IT BROKE DUE TO THE EXTRACTION WAS TOO HARD. THEREFORE, WE CONSIDER THIS COMPLAINT AS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL "THE THREAD LOOSEN INSIDE THE CASSETTE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945118 CATGUT CHROMIC 2/0 (3.5) 100M CATGUT CHROM CASSETTES GAL B. BRAUN SURGICAL SA F1154052 618084

    Patients

    Seq Age Sex Outcome Treatment
    1