BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL UD 27IN USP2-0

    MDR report key: 20533536 · Received October 25, 2024

    Report

    Report Number
    2210968-2024-11095
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Date of Event
    September 1, 2024
    Report Date
    July 21, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    UDI-DI
    10705031072688
    PMA / PMN Number
    K960653
    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). H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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 Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). CORRECTED INFORMATION: GTIN D4/G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA UNDER 510K# K960653. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803, PART 4 SUBPART B. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.

    Description of Event or Problem · 0

    VET USE: IT WAS REPORTED AN ANIMAL UNDERWENT AN CAT OOPHORECTOMY VETERINARY PROCEDURE IN (B)(6) 2024 AND SUTURE WAS USED. POST-OP, ABDOMINAL INCISIONAL WOUND DEHISCENCES WITH EVENTRATION ON 2 CATS OVARIECTOMIZED WITH MONOCRYL C1086. DURING OOPHORECTOMY, THE VETERINARIAN USES MONOCRYL C1086 FOR LIGATION OF OVARIAN PEDICLES, OVERSHOT OF THE MUSCLE WALL, SUBCUTANEOUS AND CUTANEOUS OVERSHOT. CATS WEAR A COLLAR POST-OPERATIVELY. IN (B)(6) 2024, TWO CATS WERE REVIEWED 3 TO 4 DAYS AFTER OOPHORECTOMY (EXACT DATE NOT KNOWN), FOR ABDOMINAL INCISIONAL WOUND DEHISCENCE WITH EVENTRATION. IN ALL CASES, THE MONOCRYL C1086 OF THE ABDOMINAL WALL OVERJET HAD RUPTURED, IN ITS LENGTH, THE OVERJET START AND END POINTS BEING PRESENT. THE DEHISCENCES WERE SURGICALLY REVISED, USING VICRYL; THE SCAR EVOLUTION WAS THEN NORMAL. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819792 MONOCRYL UD 27IN USP2-0 SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. TMMHQP 10705031072688

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown