BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOMEND MT 5/0 18"(45CM)HR17 (M)VPL.RCP

    MDR report key: 12792524 · Received November 11, 2021

    Report

    Report Number
    3003639970-2021-00569
    Event Type
    Malfunction
    Date Received
    November 11, 2021
    Report Date
    November 11, 2021
    Manufacturer
    B. BRAUN SURGICAL, S.A.U.
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED DEVICE MARKETED IN THE U.S. ONLY FOR VETERINARY USE, HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K011375. ANALYSIS AND RESULTS: AS NO BATCH NUMBER IS AVAILABLE, THE BATCH MANUFACTURING RECORD CANNOT BE REVIEWED. WITHOUT CLOSED SAMPLES AND/OR DEFECTIVE SAMPLES A PROPER ANALYSIS CANNOT BE PERFORMED. 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. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, PLEASE NOTE THAT WE OPENED A CAPA IN THE SYSTEM TO CORRECT/PREVENT THIS DEFECT TO HAPPEN.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH MONOMEND SUTURE. THE CLIENT (VETERINARIAN) REPORTED THAT 1/3 OF THE SUTURES OF A BOX HAVE NO NEEDLE. BEFORE APPLICATION. NO MORE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1693850 MONOMEND MT 5/0 18"(45CM)HR17 (M)VPL.RCP SYNTHETIC ABSORBABLE MONOFILAR SUTURE GAM B. BRAUN SURGICAL, S.A.U. 100523572

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown