BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVT DEVICE LCM

    MDR report key: 12530158 · Received September 24, 2021

    Report

    Report Number
    2210968-2021-08855
    Event Type
    Injury
    Date Received
    September 24, 2021
    Date of Event
    February 2, 2007
    Report Date
    November 23, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 11/23/2021. 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 INFORMATION: LOT 30271137 PROVIDED WAS DETERMINED AS AN INVALID LOT NUMBER IN THE SYSTEM DATABASE. THEREFORE, NO DHR REVIEW CAN BE PERFORMED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. (B)(4)- DEVICE NOT RETURNED. ATTEMPTS HAVE BEEN 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 ATTACHED. EVENTS ASSOCIATED WITH PATIENT'S FIRST EVENT REPORTED VIA MW #(B)(4). EVENTS ASSOCIATED WITH PATIENT'S SECOND EVENT REPORTED VIA MW #(B)(4). EVENTS ASSOCIATED WITH PATIENT'S THIRD EVENT REPORTED VIA MW #(B)(4). EVENTS ASSOCIATED WITH PATIENT'S FOURTH EVENT REPORTED VIA MW #(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT THE DEVICE ERODED THROUGH THE VAGINAL WALL CAUSING PAIN, BLEEDING, AND FURTHER PROLAPSE SCARRING. IT WAS REPORTED THAT THE PATIENT HAD AN OPERATION TO RECOVER THE EXPOSED MESH AND A AUTOLOGOUS SLING PUT IN. IT WAS ALSO REPORTED THAT THE PATIENT HAS NEVER RECOVERED AND IS NOW DOUBLE INCONTINENT WITH TWO BOWEL PROLAPSES, A BLADDER PROLAPSE, AND A RECTAL PROLAPSE. IT WAS ALSO REPORTED THAT THE PATIENT IS WAITING TO FIND IF A STOMA IS REQUIRED FOR THE REMAINDER OF LIFE. IT WAS ALSO REPORTED THAT THE PATIENT IS DISABLED AND DESTROYED BECAUSE OF MISUSE OF THE DEVICE. IT WAS ALSO REPORTED THAT THE PATIENT IS UNABLE TO WALK FAR, IS IN CONSTANT PAIN, AND HAS CUTTING, BLEEDING, AND SHARP, STABBING PAIN IN THE VAGINA AND BACK PASSAGE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427220 TVT DEVICE LCM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention