BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - RETROPUBIC UNKNOWN PRD

    MDR report key: 13241585 · Received January 12, 2022

    Report

    Report Number
    2210968-2022-00373
    Event Type
    Injury
    Date Received
    January 12, 2022
    Date of Event
    November 15, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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). IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. EVENT RELATED TO PATIENT'S FIRST EVENT REPORTED VIA MW # (B)(4). EVENT RELATED TO PATIENT'S SECOND EVENT REPORTED VIA MW # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2006 AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SMALL RECURRENT EROSION THAT WAS NOTED ON (B)(6) 2021. THE PATIENT WAS TREATED WITH VAGINAL OESTROGEN AS ATROPHIC AND SURGERY ARRANGED TO REMOVE MESH EROSION. IT WAS REPORTED THAT THE NEXT OPERATION DATE IS (B)(6) 2022. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784669 TENSION FREE VAGINAL TAPE - RETROPUBIC UNKNOWN PRD MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention