BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOMEND MT 3/0 36"(90CM)DS24 (M)VPL RCP

    MDR report key: 12598484 · Received October 8, 2021

    Report

    Report Number
    3003639970-2021-00495
    Event Type
    Malfunction
    Date Received
    October 8, 2021
    Report Date
    October 8, 2021
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    K011375; REPORTED DEVICE NOT MARKETED IN THE US, HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE US. ANALYSIS AND RESULTS: WE HAVE NOT RECEIVED THE POSSIBLE INVOLVED BATCHES. WITHOUT CLOSED SAMPLES AND/OR DEFECTIVE SAMPLES A PROPER ANALYSIS CANNOT BE PERFORMED. MOREOVER, THE BATCH MANUFACTURING RECORDS CANNOT BE REVIEWED EITHER. 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 ANALYSE 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, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ISSUE WITH MONOMEND SUTURE (VETERINARY USE ONLY PRODUCT). THE CLIENT REPORTED THAT SUTURES KEEP BREAKING IN CATS' ABDOMENS AND PRODUCING HERNIAS. NO MORE INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1495159 MONOMEND MT 3/0 36"(90CM)DS24 (M)VPL RCP SYNTHETIC ABSORBABLE MONOFILAR SUTURE GAM B. BRAUN SURGICAL, S.A. 100523566

    Patients

    Seq Age Sex Outcome Treatment
    1