BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATGUT CHROMIC 2/0 (3.5) 100M

    MDR report key: 6660297 · Received June 22, 2017

    Report

    Report Number
    3003639970-2017-00333
    Event Type
    Malfunction
    Date Received
    June 22, 2017
    Date of Event
    June 7, 2017
    Report Date
    June 22, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR ANY OTHER TECHNOLOGICAL CHARACTERISTICS WITH A MEDICAL DEVICE THAT IS REGISTERED WITHIN THE U.S. AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(4). IT WAS REPORTED THAT WHEN THE VETERINARIAN WAS USING THE CATGUT DURING A PROCEDURE, WHILE TRYING TO KNOT THE THREAD IT KEPT BREAKING. THE ANIMAL (DOG) KEPT BLEEDING WHILE THE VETERINARIAN TRIED USING ANOTHER SUTURE WHICH ALSO BROKE. TO COMPLETE THE PROCEDURE THE VETERINARIAN DECIDED TO USE ANOTHER BRAND. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 3003639970-2017-00333, 3003639970-2017-00334, 3003639970-2017-00335.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440769 CATGUT CHROMIC 2/0 (3.5) 100M SUTURES GAL B.BRAUN SURGICAL SA F1154052 616471

    Patients

    Seq Age Sex Outcome Treatment
    1 Other