BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN VIOLET 6/0 (0,7)45CM DS12(M).RCP

    MDR report key: 25327278 · Received May 29, 2026

    Report

    Report Number
    3003639970-2026-00497
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Report Date
    May 29, 2026
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 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., K011375. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH MONOSYN SUTURE. THE CLIENT REPORTED THAT THE NEEDLE COMES OFF THREAD. THERE IS NO PATIENT INVOLVEMENT. THE TYPE OF PROCEDURE IN PROGRESS WAS FLAP CLOSURE PROCEDURE THAT WAS NOT COMPLETED WITH THE SUTURE IN QUESTION. ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201959 MONOSYN VIOLET 6/0 (0,7)45CM DS12(M).RCP SYNTHETIC ABSORBABLE MONOFILAR SUTURE GAM B. BRAUN SURGICAL, S.A. C2022102 1543ZN

    Patients

    Seq Age Sex Outcome Treatment
    1