BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATGUT PLAIN 4 (8) 25M

    MDR report key: 3821465 · Received January 14, 2014

    Report

    Report Number
    2916714-2014-00025
    Event Type
    Malfunction
    Date Received
    January 14, 2014
    Report Date
    January 14, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON 12/20/2013. REPORTED DEVICE NOT MARKETED IN THE US; HOWEVER, SIMILAR DEVICE IS. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 1 CASSETTE. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL OEM REQUIREMENTS. THERE ARE NO UNITS OF THIS BATCH NUMBER IN OEM STOCK. KNOT PULL TENSILE STRENGTH OF THE SAMPLES RECEIVED WAS TESTED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE OEM. ABSORPTION CONTROLS CONDUCTED ON SAMPLE WITH COLLAGENASE AFTER A PERIOD OF TIME HAVE RETENTION STRENGTH VALUES HIGHER THAN CURRENT ONES FOR THIS MATERIAL AND SIZE. THEREFORE, THIS THREAD DOES NOT DEGRADE QUICKER THAN OTHER BATCHES TESTED. THE THREAD OF THE SAMPLE RECEIVED WAS ALMOST CONSUMED AND WE COULD NOT CONDUCT ALL DEGRADATION TESTS WITH COLLAGENASE IN ORDER TO VIEW THE DEGRADATION PROFILE. THEREFORE, AND ACCORDING TO THE PERFORMED ANALYSIS RESULTS, OEM CONSIDERS THIS COMPLAINT AS NOT CORRESPONDING. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED). ACTIONS ON PRODUCT: NOT APPLICABLE. CORRECTIVE/PREVENTIVE ACTIONS: NOT APPLICABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). DATE OF OPERATION: (B)(6) 2013. ANIMAL: (B)(6) COW. SUTURE TECHNIQUE: CONTINUOUS. DESCRIPTION: RUPTURE OF CATGUT AFTER UTERUS SUTURE, IN THE MIDDLE OF THE SUTURE (BOTH KNOTS WERE INTACT). COMPLICATIONS: SEVERE PERITONITIS AND WOUND INFECTION. FROM 4 TO 8 DAYS AFTER SURGERY. CONSEQUENCES: WOUND HEALED AND ANIMAL RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37536 CATGUT PLAIN 4 (8) 25M NONE GAL B. BRAUN SURGICAL S.A. F1144103 612481

    Patients

    Seq Age Sex Outcome Treatment
    1