BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIL VIOLET 5/0 (1) 45CM DS12 (M)

    MDR report key: 8708834 · Received June 18, 2019

    Report

    Report Number
    3003639970-2019-00476
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Report Date
    August 28, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES RECEIVED: THERE ARE NO SAMPLES AVAILABLE FOR ANALYSIS. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN STOCK. AS NO SAMPLES HAVE BEEN RECEIVED AND NO UNITS ARE AVAILABLE IN B. BRAUN SURGICAL, S.A., WE HAVE ONLY REVIEWED THE BATCH MANUFACTURING RECORD AND THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. ADDITIONALLY, WE HAVE CONDUCTED A REVIEW OF THE COMPLAINT HISTORY RECORD OF THE PRODUCTS MANUFACTURED WITH THE SAME THREAD RAW MATERIAL BATCH AS THE USED IN THIS PRODUCT, AND THERE ARE NO OTHER COMPLAINTS IN THE OTHER PRODUCTS. FINAL CONCLUSION: WITHOUT SAMPLES WE ARE NOT IN POSITION OF STUDYING IF THE AFFECTED PRODUCT DOES NOT FULFIL THE SPECIFICATIONS. IN CONSEQUENCE, A PROPER ANALYSIS CANNOT BE DONE AND THE CASE IS NOT CONFIRMED DUE TO LACK OF EVIDENCE. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYZE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED. ACTIONS ON PRODUCT DISTRIBUTED OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012 G5: REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K980704 WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE THREAD LOOSENED. THE REPORTER INDICATED THAT 20 DAYS AFTER AN ORTHOPEDIC PROCEDURE IT WAS FOUND THE PATIENTS WOUND BECAME REDDENED AND SWOLLEN. THE SURGEON HAD USED INTERRUPTED SUTURE TECHNIQUE AND USED 4-5 KNOTS FOR AN ORTHOPEDIC SURGICAL SUTURE FLAP. ATER OPENING THE WOULD, IT WAS FOUND THE PATIENT'S STITCHES WERE LOOSE AND BROKEN, RESULTING IN POOR WOUND HEALING, AND SOME TISSUE NECROSIS OCCURRED. THE PATIENT REQUIRED RE-SUTURING AND WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503093 SAFIL VIOLET 5/0 (1) 45CM DS12 (M) SYNTHETIC ABSORBABLE BRAIDED S GAM B.BRAUN SURGICAL SA C1048416

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention