BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT

    MDR report key: 22063132 · Received May 21, 2025

    Report

    Report Number
    2210968-2025-05691
    Event Type
    Injury
    Date Received
    May 21, 2025
    Date of Event
    April 22, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K132054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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: LIFE-THREATENING ILLNESS OR INJURY: NO PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION: NO REQUIRED IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION: NO RESULTED IN MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION: NO DRUG THERAPY: NO SURGICAL PROCEDURE, THERAPY, OR INTERVENTION: YES SPECIFY: TAPE LOOSENING IN LOCAL ANESTHESIA NON-SURGICAL PROCEDURE, THERAPY, OR INTERVENTION: NO BLOOD TRANSFUSION: NO OTHER: NO DID THIS EVENT RESULT IN THE PATIENT¿S DISCONTINUATION OF THE STUDY? NO 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 THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WERE ANY CONCOMITANT PROCEDURES PERFORMED? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? HOW WAS THE URINARY RETENTION CONFIRMED? PLEASE DESCRIBE ANY MEDICAL INTERVENTION REQUIRED TO TREAT THE URINARY RETENTION INCLUDING MEDICATION NAME AND RESULTS. PLEASE PROVIDE THE DATE AND SURGICAL FINDINGS OF ANY REOPERATION/TAPE LOOSENING PERFORMED. DOES THE SURGEON BELIEVE THE URINARY RETENTION IS FUNCTIONAL OR STRUCTURAL IN NATURE? A. FUNCTIONAL: THE LOCAL SURGICAL TRAUMA AND THE ANESTHETICS IN COMBINATION WITH OTHER PATIENT RELATED ISSUES. B. STRUCTURAL: IF A PELVIC MESH OR SUB-URETHRAL SLING WAS PHYSICALLY OBSTRUCTED THE URINARY TRACT AT THE LEVELS OF URETERS OR URETHRA. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? SURGEON¿S NAME? FACILITY NAME? COUNTRY OF EVENT? PRODUCT CODE AND LOT NUMBER? D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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

    PRODUCT COMPLAINT #(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. UPDATED INFORMATION RECEIVED: ADVERSE EVENT TERM: URINATING TAKES A BIT LONGER UPDATED: IF THE EVENT IS MARKED AS BEING RELATED TO THE PROCEDURE, INDICATE WHICH PROCEDURE THE EVENT IS RELATED TO : BLANK => INDEX

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (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 RECEIVED: ADVERSE EVENT TERM: URINATING TAKES A BIT LONGER. START DATE: (B)(6) 2025. ADDITIONAL EVENT DETAILS. SITE AWARENESS DATE: 23 OCT 2025. END DATE: BLANK. SEVERITY: MILD. IS THE ADVERSE EVENT SERIOUS? NO. DEATH: NO. DATE OF DEATH: BLANK. LIFE-THREATENING ILLNESS OR INJURY: NO. PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION: NO REQUIRED IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION: NO ADMISSION DATE: BLANK DISCHARGE DATE: BLANK RESULTED IN MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION: NO LED TO FETAL DISTRESS, FETAL DEATH OR A CONGENITAL ABNORMALITY OR BIRTH DEFECT: NO RELATIONSHIP TO STUDY DEVICE: NOT RELATED IF EVENT IS SERIOUS AND DEVICE RELATED (UNLIKELY, POSSIBLE, PROBABLE, OR CAUSAL RELATIONSHIP), ACCORDING TO THE PROTOCOL AND INSTRUCTIONS FOR USE, IN THE OPINION OF THE INVESTIGATOR, IS THE ADVERSE EVENT EXPECTED/ANTICIPATED? N/A RELATIONSHIP TO PRIMARY STUDY PROCEDURE: CAUSAL RELATIONSHIP IF THE EVENT IS MARKED AS BEING RELATED TO THE PROCEDURE, INDICATE WHICH PROCEDURE THE EVENT IS RELATED TO: BLANK IF PROCEDURE RELATED AND REPEAT/RETREATMENT IS SELECTED, SPECIFY DATE: BLANK. INTERVENTION/TREATMENT: NONE: YES. DRUG THERAPY: NO. SURGICAL PROCEDURE, THERAPY, OR INTERVENTION: NO. SPECIFY: BLANK. NON-SURGICAL PROCEDURE, THERAPY, OR INTERVENTION: NO. SPECIFY: BLANK. BLOOD TRANSFUSION: NO. OTHER: NO. IF OTHER SPECIFY: BLANK. OUTCOME: NOT RECOVERED/NOT RESOLVED. DID THIS EVENT RESULT IN THE PATIENT¿S DISCONTINUATION OF THE STUDY? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2025 AND MESH WAS IMPLANTED. ON (B)(6) 2025, MODERATE RESIDUAL URINE WAS NOTED. THE PATIENT UNDERWENT TAPE LOOSENING IN LOCAL ANESTHESIA AND THE EVENT WAS RECOVERED/RESOLVED WITHOUT SEQUALAE AS OF (B)(6) 2025. THIS WAS REPORTED AS NOT RELATED TO THE STUDY DEVICE, BUT HAVING A CAUSAL RELATIONSHIP WITH THE STUDY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180603 TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1