BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVT EXACT RETROPUBIC SYSTEM

    MDR report key: 9833047 · Received March 14, 2020

    Report

    Report Number
    2210968-2020-02096
    Event Type
    Injury
    Date Received
    March 14, 2020
    Date of Event
    September 1, 2019
    Report Date
    February 21, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031062375
    PMA / PMN Number
    K132054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE 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. THE PATIENT DEMOGRAPHIC INFO: AGE, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE INDICATION AND INITIAL APPROACH FOR (B)(6) 2019 INITIAL SURGICAL PROCEDURE? ANY CONCURRENT PROCEDURE/DEVICE IMPLANTATION? WERE THERE ANY INTRA-OPERATIVE COMPLICATIONS? OTHER RELEVANT PATIENT COMORBIDITIES/CONCOMITANT MEDICATIONS? SURGICAL FINDINGS OF REVISION SURGERY IN (B)(6) 2020? WHAT ARE CULTURE RESULTS? WHAT IS PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THESE EVENTS? WHAT IS THE PATIENT'S CURRENT STATUS? IF APPLICABLE, WILL PRODUCT TVTRL (LOT 3932462) BE RETURNED, RETURN DATE, TRACKING INFORMATION?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2019 AND THE MESH WAS IMPLANTED. BY (B)(6) 2019, THE PATIENT WAS EXPERIENCING PAIN IN THE VAGINA, WHEN WAS SITTING, DURING INTERCOURSE AND WHEN USING VAGINAL SUPPOSITORY VAGIFEM. A VAGINAL EXAMINATION REVEALED A MESH EROSION 8X10MM, AND THE DOCTOR COULD SEE THE SYNTHETIC MESH. IN (B)(6) 2019 A CYSTOSCOPY CONFIRMS THE MESH SLING ERODED THROUGH VAGINAL MUCOSA, THE BLADDER MUCOSA WAS NOTICEABLE WITHOUT EROSION. IN (B)(6) 2020 DURING THE SURGERY, A MESH EROSION WAS FOUND 15X15 IN THE VAGINAL MUCOSA AND MESH WAS THICKENED. 20MM OF THE MESH WAS CUT OFF AND THE MESH PIECE SENT FOR CULTIVATION FOR ACTINOMYCES. THE VAGINAL MUCOSA WAS TRIMMED AND CLOSED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS POSTOPERATIVELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296383 TVT EXACT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. TVTRL 3932462 10705031062375

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention