BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL PELVIC FLOOR REPAIR SYST

    MDR report key: 18865872 · Received March 8, 2024

    Report

    Report Number
    2210968-2024-02729
    Event Type
    Injury
    Date Received
    March 8, 2024
    Date of Event
    April 11, 2011
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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. TO DATE IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE FOR PELVIC PROLAPSE ON (B)(6) 2011 AND MESH WAS IMPLANTED. MS MONARC SLING WAS IMPLANTED TO HELP WITH BLADDER AND BOWEL INCONTINENCE. STRAIGHT AFTER THE PROCEDURE, THE PATIENT REPORTED HAVING PAIN AND THE INCONTINENCE BLADDER AND BOWEL WAS WORSE THAN BEFORE. ALL OF THESE SYMPTOMS PERSISTED AS WELL AS NUMBNESS DOWN LEFT LEG AND PAIN IN BOTH PELVIC SIDES BUT MORE SO DOWN THE RIGHT SIDE. TWELVE MONTHS LATER, A 2ND AMS MONARC SLING WAS IMPLANTED, HOPING IT WOULD IMPROVE THE SITUATION, WHICH IT DID NOT. A SPECIMEN OF MESH WAS REMOVED WHEN THE OPERATION WAS BEING DONE OF THE PROLAPSE MESH AND SENT TO PATHOLOGY. IT CAME BACK SHOWING FOREIGN BODY REACTION FROM THE MESH. THE PATIENT FURTHER REPORTED MAJOR DEPRESSION, ANXIETY, SCOLIOSIS AND SLEEP APNEA. IN 2019, A 3D4D ULTRASOUND WAS DONE AND THE 2 SLINGS HAD TURNED AND WERE ON THEIR SIDE HEADING TOWARDS THE URETHRA. THE PATIENT HAS HAD NUMEROUS SESSIONS OF SITTING ON A NEO CONTROL CHAIR TO TRY AND HELP, BUT WITH NO RESULTS AND THE PATIENT ALSO COULDN¿T HAVE THE MACHINE HIGH AS IT WAS GIVING MORE PAIN. NUMEROUS PHYSIO CONSULTATIONS TO NO ADVANTAGE. SINCE 2011, THE PATIENT HAS EXPERIENCED INCONTINENCE OF BLADDER AND BOWEL, CONTINUOUS PELVIC PAIN, NUMBNESS DOWN LEFT LEG, OSTEO ARTHRITIS, LOWER BACK PAIN, PINS AND NEEDLES IN LEFT FOOT, CONSTIPATION AND MENTAL TRAUMA. NO FURTHER INFORMATION IS AVAILABLE AS REPORTER DETAILS HAVE NOT BEEN DISCLOSED (CONFIDENTIAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741848 TOTAL PELVIC FLOOR REPAIR SYST MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. 3413190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention