BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTILENE 6/0 (0,7) 75CM 2XDR13 CV2 RCP

    MDR report key: 24614811 · Received March 17, 2026

    Report

    Report Number
    3003639970-2026-00339
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    February 11, 2026
    Report Date
    May 14, 2026
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAW
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    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., 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 ON (B)(6) 2026, DURING SURGERY, THE SUTURE DELAMINATED. THE PATIENT RECOVERED WITHOUT COMPLICATIONS. ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95075 OPTILENE 6/0 (0,7) 75CM 2XDR13 CV2 RCP CARDIAC SUTURE GAW B. BRAUN SURGICAL, S.A. C3097906 125101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female