BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL RAP UND 70CM M3 USP2/0 SGLE CTB-1

    MDR report key: 20504705 · Received October 22, 2024

    Report

    Report Number
    2210968-2024-10893
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    August 5, 2024
    Report Date
    October 22, 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: WERE THERE ANY PATIENT CONSEQUENCES? DID ANY NEEDLE PIECE FALL INTO THE PATIENT? IF YES, WAS THE NEEDLE PIECE(S) RETRIEVED DURING THE SAME PROCEDURE? WERE X-RAYS TAKEN TO LOCATE THE NEEDLE PIECE(S)? WHAT MEASURES WERE TAKEN TO RETRIEVE THE BROKEN PIECE? WAS THERE ANY ADDITIONAL TISSUE DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE PIECE? IF NOT RETRIEVED, IN WHAT TISSUE STRUCTURE THE BROKEN NEEDLE WAS RETAINED? IS THERE ANY PLAN IN PLACE TO REMOVE THE NEEDLE PIECE IN THE FUTURE? PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF THE EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP) CONTACTED WITH THE SALES REP TODAY VIA PHONE, PLEASE REFER TO EVENT DESCRIPTION AND 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 DELIVERY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE MOTHER GAVE BIRTH TO A LIVE MALE BABY AT 3:57. AFTER THE PLACENTA WAS DELIVERED, THE VAGINAL LACERATION WAS SUTURED. DURING THE NORMAL SUTURING OF THE VAGINAL WALL LACERATION WOUND, THE NEEDLE BROKE AND WAS REMOVED BY THE DOCTOR UNDER ULTRASOUND GUIDANCE. NOTIFY THE DEPARTMENT TO REPLACE SUTURES AND STRENGTHEN OBSERVATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956950 VICRYL RAP UND 70CM M3 USP2/0 SGLE CTB-1 SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM ETHICON INC. RACCJPZ8

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female