BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL RAP UND 30IN USP4-0 S/A FS-1

    MDR report key: 25153037 · Received May 12, 2026

    Report

    Report Number
    2210968-2026-05188
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 19, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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: ADDITIONAL EVENT INFORMATION RECEIVED FROM THE CUSTOMER: THE INTERVENTION IS A LITTLE LONGER BECAUSE IT IS NECESSARY TO OPEN MORE WIRES SO RISK HAVING NEW WIRES THAT LOOSEN. AND THAT MAKES MORE KNOTS IN THE SCAR BECAUSE WE TAKE THE SUTURE WHERE THE THREAD BROKE. "D4/G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THEREFORE, (01) GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, WE HAVE ABOUT ONE THREAD OUT OF TWO THA GOT LOOSENED. AGAIN, THIS AFTERNOON AND THIS MORNING (29 APRIL) WHEN WE DO THE OVERJETS, AFTER 2 OR 3 PASSAGE THE NEEDLE HAD DROPPED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97667 VICRYL RAP UND 30IN USP4-0 S/A FS-1 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. AX2101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown