BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK BRD BLK 15X60CM M2.5

    MDR report key: 23479358 · Received November 5, 2025

    Report

    Report Number
    2210968-2025-12534
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    July 5, 2025
    Report Date
    November 5, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    UDI-DI
    16921799018032
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: PRODUCT CODE SHOULD BE SA845G . LOT NUMBER SHOULD BE XD2AK . CAN YOU IDENTIFY THE LOT NUMBER OF THE PRODUCT USED? XD2AK. WHAT IS THE PROCEDURE NAME AND DATE? THE PROCEDURE NAME IS UNKNOWN AND PROCEDURE DATE IS (B)(6) 2025. WERE THERE ANY PATIENT CONSEQUENCES? NO

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2465251 SILK BRD BLK 15X60CM M2.5 SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. XD2AK 16921799018032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown