BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVT EXACT RETROPUBIC SYSTEM

    MDR report key: 17712486 · Received September 8, 2023

    Report

    Report Number
    2210968-2023-06513
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    June 15, 2023
    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 · 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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE NAME OF INDEX SURGICAL PROCEDURE? THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WERE ANY CONCOMITANT PROCEDURES PERFORMED? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? WERE THERE ANY INTRA-OPERATIVE COMPLICATIONS? PLEASE PROVIDE THE MESH EXPOSURE SITE/LOCATION, SYMPTOMS AND DIAGNOSTIC CONFIRMATION. DESCRIBE THE SURGICAL INTERVENTION FOR THE EXPOSURE INCLUDING FINDINGS. WAS THE EXPOSED MESH SUCCESSFULLY EXCISED? WERE ANY DEFICIENCIES OR ANOMALIES NOTED WITH MESH DEVICE? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? PRODUCT LOT NUMBER? 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2023 AND MESH WAS IMPLANTED. ON (B)(6) 2023, THE PATIENT WAS REFERRED WITH THE DIAGNOSIS OF EROSION OF MESH. NO EFFECT HOWEVER, THE PATIENT EXPERIENCED PAIN FROM THE VAGINA DEEP TO THE LEFT. INDICATION FOR REMOVAL OF THE SLING. ON (B)(6) 2023, THE PATIENT UNDERWENT REMOVAL OF FOREIGN BODY FROM THE VAGINA. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897720 TVT EXACT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 10705031062375

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention