BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCRYL UD 27IN 3-0 S/A PS-1 PRM MP

    MDR report key: 18163600 · Received November 17, 2023

    Report

    Report Number
    2210968-2023-09016
    Event Type
    Malfunction
    Date Received
    November 17, 2023
    Date of Event
    October 24, 2023
    Report Date
    November 29, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    UDI-DI
    10705031059917
    PMA / PMN Number
    K964072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: ADDITIONAL INFORMATION REQUESTED: - DID THE Y936H NEEDLE FALL INTO THE PATIENT? NO 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? - DOES A PIECE OF THE NEEDLE (Y936H) REMAIN IN THE PATIENT¿S TISSUE? NO IF YES, ¿ IS THERE ANY PLAN IN PLACE TO REMOVE THE NEEDLE PIECE IN THE FUTURE? ¿ IF YES, PLEASE PROVIDE THE SCHEDULED DATE. ¿ WHAT TISSUE STRUCTURE THE BROKEN NEEDLE WAS LOCATED? ¿ WHAT IS THE SURGEON'S OPINION OF CONSEQUENCES TO THE PATIENT? - PLEASE CONFIRM THE LOT # REPORTED FOR J345H INVOLVED (A3E0197Y): - PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS: ALVARO VENEGAS QF

    Additional Manufacturer Narrative · 0

    (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. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DID THE Y936H NEEDLE 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? DOES A PIECE OF THE NEEDLE (Y936H) REMAIN IN THE PATIENT¿S TISSUE? IF YES, IS THERE ANY PLAN IN PLACE TO REMOVE THE NEEDLE PIECE IN THE FUTURE? IF YES, PLEASE PROVIDE THE SCHEDULED DATE. WHAT TISSUE STRUCTURE THE BROKEN NEEDLE WAS LOCATED? WHAT IS THE SURGEON'S OPINION OF CONSEQUENCES TO THE PATIENT?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE CUT FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674129 MCRYL UD 27IN 3-0 S/A PS-1 PRM MP SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. AU4287 10705031059917

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown