BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL RAP UND 90CM M3 USP2/0 SGLE CTB-1

    MDR report key: 20675560 · Received November 13, 2024

    Report

    Report Number
    2210968-2024-11956
    Event Type
    Malfunction
    Date Received
    November 13, 2024
    Date of Event
    October 18, 2024
    Report Date
    November 13, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: RECEIVED INFORMATION AS FOLLOWING FROM SALES REP VIA PHONE TODAY. - PLEASE CLARIFY IF THERE WERE CONSEQUENCES FOR THE PATIENT. - HOW LONG WAS THE DELAY? - WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? - WAS THERE ANY CHANGE IN THE PATIENT¿S POST-OPERATIVE CARE DUE TO THE PROLONGED PROCEDURE? --PLEASE REFER TO THE EVENT DESCRIPTION, OTHER INFORMATION REQUESTED IS UNKNOWN. D4: UDI: (01)GTIN UNAVAILABLE, PRODUCT MADE PRIOR TO GTIN COMPLIANCE DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL PROCEDURE ON (B)(6) 2024AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT GAVE BIRTH AT 08:40 AND UNDERWENT SURGERY. THE DOCTOR SUTURED THE WOUND. TWO STITCHES WERE SUTURED IN THE VAGINA, AND DURING THE THIRD STITCH, THE NEEDLE ENTERED THE VAGINAL MUCOSA. THE RECIPIENT'S LEFT AND RIGHT HANDS COOPERATED WITH EACH OTHER. WHEN ALL THE NEEDLE WERE INSERTED INTO THE VAGINAL MUCOSA, IT WAS FOUND THAT THE SUTURE HAD BROKEN OFF FROM THE TAIL OF THE NEEDLE ON ITS OWN. RESULTING IN PROLONGED SUTURE TIME. IMMEDIATELY REMOVE THE DISCONNECTED NEEDLE FROM THE VAGINAL MUCOSA AND CHECK FOR ANY DEFECTS IN THE NEEDLE. REPLACED THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2422371 VICRYL RAP UND 90CM M3 USP2/0 SGLE CTB-1 SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM ETHICON INC. TGCDTQZ0

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female