BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML

    MDR report key: 9755041 · Received February 26, 2020

    Report

    Report Number
    3003639970-2020-00122
    Event Type
    Injury
    Date Received
    February 26, 2020
    Report Date
    March 17, 2020
    Manufacturer
    B. BRAUN SURGICAL SA
    Product Code
    MPN
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SAMPLES RECEIVED: (B)(4) OPEN POUCH (CONTAINS AN UNOPENED AMPOULE). 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 OUR STOCK. WE HAVE RECEIVED ONE OPEN POUCH THAT CONTAINS AN UNOPENED AMPOULE. WE HAVE CHECKED THE AMPOULE RECEIVED AND NO DEFECTS HAVE BEEN FOUND. WE HAVE ALSO CONDUCTED A REVIEW OF THE BATCH MANUFACTURING RECORD OF THIS PRODUCT, AND NO DEVIATIONS HAVE BEEN FOUND. ACCORDING TO THE INFORMATION RECEIVED, THE CUSTOMER USED HISTOACRYL GLUE WITH A PÉTERS APPLICATOR (REFERENCE MB37S). WE HAVE CHECKED THE INSTRUCTIONS FOR USE OF THIS APPLICATOR AND IT IS STATED THAT COMPATIBILITY STUDIES HAVE BEEN CONDUCTED WITH IFABOND SURGICAL GLUE. IT IS THEREFORE STRONGLY ADVISED NOT TO USE THESE APPLICATORS WITH OTHER TYPES OF GLUE AND TO READ THE INSTRUCTIONS FOR USE OF SURGICAL GLUES BEFORE USING THEM. THE POLYMERIZATION TIME OF BOTH ADHESIVES IS DIFFERENT. HISTOACRYL GLUE HAS A SHORTER TIME OF POLYMERIZATION THAN IFABOND GLUE AND IT COULD CAUSE THAT THE GLUE POLYMERIZED IN THE APPLICATOR USED BEFORE GLUE APPLICATION. REMARKS: WE RECOMMEND TO USE HISTOACRYL LAPFIX THAT IS DESIGNED FOR EXCLUSIVE USE WITH HISTOACRYL OR HISTOACRYL PRO-SET OFX. FINAL CONCLUSION: IN SPITE OF RECEIVING AN OPEN SAMPLE, TAKING INTO ACCOUNT THE INFORMATION RECEIVED WE CONSIDER THAT THE CASE IS NOT CONFIRMED AS IT IS USED WITH AN APPLICATOR THAT IT IS NOT INDICATED. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. 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 · 1

    K140343 PMA/510K: 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. WHEN ADDITIONAL INFORMATION/INVESTIGATION RESULTS BECOME AVAILABLE, RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE HISTOACRYL TRANSLUCENT. THE CUSTOMER REPORTED THAT THERE WAS CRYSTALLIZATION AT THE END OF THE APPLICATOR. USED FOR INGUINAL HERNIAS. FURTHER INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221391 HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML TISSUE ADHESIVES MPN B. BRAUN SURGICAL SA 1050071 219351N2

    Patients

    Seq Age Sex Outcome Treatment
    1