BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT SECUR -TENSION-

    MDR report key: 12841227 · Received November 18, 2021

    Report

    Report Number
    2210968-2021-11731
    Event Type
    Injury
    Date Received
    November 18, 2021
    Report Date
    November 18, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EMDR REPRESENTS SUPPLEMENTAL REPORT #2210968-2017-04002 FOR PREVIOUSLY SUBMITTED MDR NUMBER 2210968-2017-03628 SUBJECT OF A LITIGATION COMPLAINT SUMMARY EXEMPTION NO. E2013037. THE REFERENCED EXEMPTION WAS REVOKED EFFECTIVE MAY 15, 2019. THE REPORTS PREVIOUSLY SUBMITTED AS PART OF THE EXEMPTION WERE NOT SUBMITTED IN A FORMAT COMPATIBLE WITH THE PUBLIC MDR DATABASE (MAUDE) AND ARE AVAILABLE THROUGH FDA¿S MDR DATA FILES WEBPAGE, AT HTTPS://WWW.FDA.GOV/MEDICAL-DEVICES/MEDICAL-DEVICE-REPORTING-MDR-HOW-REPORT-MEDICAL-DEVICE-PROBLEMS/MDR-DATA-FILES#ASR. THEREFORE, THIS REPORT DOES NOT REPRESENT A NEW REPORTABLE EVENT. THE INFORMATION INCLUDED IN THIS REPORT WAS SUBMITTED OUTSIDE THE REQUIRED TIMEFRAME DUE TO THE EXTENDED USE OF EXEMPTION E2013037 BEYOND ITS REVOKE DATE, AS DOCUMENTED UNDER (B)(4) (ETHICON¿S INTERNAL REFERENCE NUMBER). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 0

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT CONCURRENTLY UNDERWENT TOTAL LAPAROSCOPY HYSTERECTOMY, PLACEMENT OF ON-Q. IT WAS REPORTED THAT FOLLOWING THE PROCEDURE, SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737510 GYNECARE TVT SECUR -TENSION- MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC PAH ETHICON INC. 3003257

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention