BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVT EXACT RETROPUBIC SYSTEM

    MDR report key: 18494839 · Received January 11, 2024

    Report

    Report Number
    2210968-2024-00326
    Event Type
    Injury
    Date Received
    January 11, 2024
    Date of Event
    November 27, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    UDI-DI
    10705031062375
    PMA / PMN Number
    K132054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE FEMALE, 172LBS, 28.65. NAME OF INDEX SURGICAL PROCEDURE? SLING OPERATION FOR STRESS INCONTINENCE. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? STRESS INCONTINENCE. WERE ANY CONCOMITANT PROCEDURES PERFORMED? YES. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? SEE EDC. WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? RETROPUBIC ? NOT SURE WHAT THEY ARE LOOKING FOR HERE. WERE ANY CONCURRENT DEVICES IMPLANTED? YES ¿ VERTESSA LITE Y. WERE THERE ANY INTRA-OPERATIVE COMPLICATIONS? NONE. PLEASE DESCRIBE ANY MEDICAL INTERVENTION GIVEN INCLUDING MEDICATION NAME AND RESULTS. NO MEDICATION GIVEN. PLEASE DESCRIBE ANY SURGICAL INTERVENTION INCLUDING DATES AND FINDINGS. REMOVAL OR REVISION OF SUBURETHRAL SLING ¿ (B)(6) 2023 ¿ TRANSECTED IN THE MIDDLE OF MESH SLING WERE ANY DEFICIENCIES OR ANOMALIES NOTED WITH MESH DEVICE? NONE WERE NOTED IN THE SURGEONS OP NOTE. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? VOIDING DYSFUNCTION/ URINARY RETENTION ¿ SLING TOO TIGHT. WHAT IS THE PATIENT'S CURRENT STATUS? RECOVERED. PRODUCT CODE AND LOT NUMBER? TVTRL - 3944594.

    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. 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. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING GENDER, 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 ANY CONCURRENT DEVICES IMPLANTED? WERE THERE ANY INTRA-OPERATIVE COMPLICATIONS? PLEASE DESCRIBE ANY MEDICAL INTERVENTION GIVEN INCLUDING MEDICATION NAME AND RESULTS. PLEASE DESCRIBE ANY SURGICAL INTERVENTION INCLUDING DATES AND FINDINGS. 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 CODE AND LOT NUMBER? SURGEON¿S NAME? FACILITY NAME? 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.

    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. 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 SLING PROCEDURE ON (B)(6) 2023 AND MESH WAS IMPLANTED. ON (B)(6) 2023, MILD DYSURIA AND MODERATE VOIDING DYSFUNCTION WERE NOTED. UNSPECIFIED DRUG THERAPY WAS PROVIDED FOR THE DYSURIA. AS OF (B)(6) 2023, THE DYSURIA HAS BEEN RECOVERED/RESOLVED WITHOUT SEQUELAE. AS OF (B)(6) 2023, THE VOIDING DYSFUNCTION HAS BEEN RECOVERED/RESOLVED WITHOUT SEQUELAE. THE DYSURIA WAS REPORTED AS POSSIBLY RELATED TO THE STUDY DEVICE AND STUDY PROCEDURE. THE VOIDING DYSFUNCTION WAS REPORTED AS PROBABLY RELATED TO THE STUDY DEVICE AND HAVING A CAUSAL RELATIONSHIP WITH THE STUDY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954739 TVT EXACT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3944594 10705031062375

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention