BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL® LAPFIX X1

    MDR report key: 8659385 · Received May 31, 2019

    Report

    Report Number
    3003639970-2019-00459
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    Report Date
    July 30, 2019
    Manufacturer
    B/ BRAUN SURGICAL SA
    Product Code
    MPN
    PMA / PMN Number
    K111959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED 1 OPEN UNIT THAT ONLY CONTAINS ONE CLOSED POUCH OF HISTOACRYL OF THE CODE-BATCH 1050044-218445N2 AND THREE CLOSED SAMPLES THAT EACH ONE CONTAINS TWO CLOSED SAMPLES OF HISTOACRYL CODE-BATCH 1050044-218445N2. THERE ARE NO PREVIOUS COMPLAINTS OF HISTOACRYL CODE-BATCH 1050044-218445N2. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. A REVIEW OF THE BATCH MANUFACTURED RECORD OF THIS PRODUCT HAS BEEN CONDUCTED AND NO DEVIATIONS HAVE BEEN FOUND. THE CLOSED HISTOACRYL SAMPLES HAVE BEEN TESTED FOR ADHESIVE STRENGTH. ADHESIVE STRENGTH RESULT OF THE CLOSED SAMPLES RECEIVED IS 899,85 N IN AVERAGE, WELL ABOVE THE REQUIREMENT WHICH IS 20 N. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE SAMPLES RECEIVED FULFIL THE B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE HISTOACRYL. IT WAS NOTED THAT THE "APPLICATOR DOES NOT STICK AS USUAL". THE PRODUCT INVOLVED WAS HISTOACRYL LAPFIX. FURTHER INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED.

    Description of Event or Problem · 0

    FURTHER DETAILS WERE PROVIDED: DURING FIXATION OF OPTILENE MESH (5 X 10 CM) THE GLUE DID NOT STICK AT ONE FIXATION POINT; THE ADHESIVE FORCE SEEMED TO BE TOO LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452970 HISTOACRYL® LAPFIX X1 MESH PRODUCTS MPN B/ BRAUN SURGICAL SA 1052008 P190208004

    Patients

    Seq Age Sex Outcome Treatment
    1