BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTILENE 3/0 (2) 90CM 2XHR26 CV RCP

    MDR report key: 25012444 · Received April 28, 2026

    Report

    Report Number
    3003639970-2026-00410
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    January 28, 2026
    Report Date
    May 11, 2026
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAW
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. UNDER PMA/510(K) NUMBER: K133890. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH OPTILENE SUTURE. THE CLIENT REPORTED THAT THE SUTURES SPLIT INTO TWO THREADS.THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371255 OPTILENE 3/0 (2) 90CM 2XHR26 CV RCP CARDIAC SUTURE GAW B. BRAUN SURGICAL, S.A. C3090908 125193

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown