BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVT DEVICE LCM

    MDR report key: 11714666 · Received April 23, 2021

    Report

    Report Number
    2210968-2021-03695
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    February 12, 2021
    Report Date
    March 26, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 06/24/2021. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.   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, 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 Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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. IF IN YOUR POSSESSION, MAY WE HAVE A COPY OF YOUR OPERATIVE REPORT? DOES ETHICON HAVE YOUR PERMISSION TO CONTACT YOUR SURGEON, IN THE EVENT ETHICON WOULD LIKE TO CONTACT YOUR SURGEON FOR MORE CLINICAL INFORMATION TO BE USED FOR A PRODUCT QUALITY COMPLAINT INVESTIGATION? IF SO, PLEASE PROVIDE YOUR SURGEON¿S NAME, CONTACT INFORMATION AND SIGN RELEASE OF MEDICAL INFORMATION FORM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADVERSE EVENTS PERTAINING TO PATIENT'S FIRST EVENT REPORTED VIA MW # 2210968-2021-03694.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROLAPSE REPAIR PROCEDURE ON 04/20/2015 AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT'S PAIN CONTINUED. IT WAS REPORTED THAT THE PATIENT SAW A MESH SPECIALIST WHO OPINED THAT THE MESH WAS ROLLED UP UNDER THE URETHRA AND THERE WAS A TENDER RIDGE IN THE LEFT SUPRAPUBIC REGION WHICH WAS POSSIBLY THE TAPE. IT WAS REPORTED THAT UPON REMOVAL, THE DEVICE WAS FOUND TO BE IN THE WRONG POSITION AS THE LEFT ARM WAS MEDIAL ABOVE THE RECTUS SHEATH. IT WAS ALSO REPORTED THAT THE MESH WAS VISIBLE AND ALMOST PROTRUDING THROUGH THE VAGINAL SKIN. HISTOLOGY SHOWED CHRONIC INFLAMMATORY CELL REACTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615650 TVT DEVICE LCM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3821526

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention