TVT EXACT RETROPUBIC SYSTEM
Report
- Report Number
- 2210968-2025-06735
- Event Type
- Injury
- Date Received
- June 12, 2025
- Date of Event
- May 12, 2025
- Report Date
- April 10, 2026
- Manufacturer
- ETHICON INC.
- Product Code
- OTN
- UDI-DI
- 10705031062375
- PMA / PMN Number
- K132054
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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: H6. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.
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: E1, H6 ADDITIONAL INFORMATION RECEIVED: ADVERSE EVENT TERM: DIFFICULTIES TO EMPTY THE BLADDER START DATE: (B)(6) 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: POSSIBLE IF THE EVENT IS MARKED AS BEING RELATED TO THE PROCEDURE, INDICATE WHICH PROCEDURE THE EVENT IS RELATED TO: INDEX IF PROCEDURE RELATED AND REPEAT/RETREATMENT IS SELECTED, SPECIFY DATE: BLANK INTERVENTION/TREATMENT: NONE: NO 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: UNKNOWN, 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? WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? WERE CULTURES PERFORMED? IF SO, PLEASE PROVIDE THE RESULTS. PLEASE DESCRIBE ANY MEDICAL INTERVENTION PERFORMED INCLUDING MEDICATION NAME AND RESULTS. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THE INFECTION AND DIFFICULTIES TO EMPTY THE BLADDER? WHAT IS THE PATIENT'S CURRENT STATUS? SURGEON¿S NAME? FACILITY NAME? PRODUCT CODE AND LOT NUMBER?
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: A4, B6, B7, D1, D4, E1, H4. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? SUI WERE ANY CONCOMITANT PROCEDURES PERFORMED? NO OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? PERINEORAPHY 2017, CERVICAL RESECTION 2024. WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? NO. DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? YES, PROPHYLACTIC ANTIBIOTICS INTRA OPERATION ACCORDING TO ROUTINE. WERE CULTURES PERFORMED? IF SO, PLEASE PROVIDE THE RESULTS. YES, (B)(6) 2025. URINE CULTURE SHOWS E-COLI. PLEASE DESCRIBE ANY MEDICAL INTERVENTION PERFORMED INCLUDING MEDICATION NAME AND RESULTS. EUSAPRIM WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THE INFECTION AND DIFFICULTIES TO EMPTY THE BLADDER? E-COLI URINARY CULTURE VERIFIED URINARY TRACT INFECTION IS THE ONLY FINDING TO BE THE CONTRIBUTING FACTOR TO THE DIFFICULTY TO TEMPORARILY EMPTY THE URINARY BLADDER. WHAT IS THE PATIENT'S CURRENT STATUS? WELL-BEING PRODUCT CODE AND LOT NUMBER? TVT EXACT, LOT NUMBER: 3944950.
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: DIFFICULTIES TO EMPTY THE BLADDER. INTERVENTION/TREATMENT: NONE: YES. OUTCOME: RECOVERED/RESOLVED WITHOUT SEQUELAE. END DATE: (B)(6) 2025.
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 PROVIDED: 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: POSSIBLE IF THE EVENT IS MARKED AS BEING RELATED TO THE PROCEDURE, INDICATE WHICH PROCEDURE THE EVENT IS RELATED TO: INDEX IF PROCEDURE RELATED AND REPEAT/RETREATMENT IS SELECTED, SPECIFY DATE: BLANK INTERVENTION/TREATMENT: NONE: NO. DRUG THERAPY: YES. 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: BLANK. 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? WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? DID THE PATIENT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS PRE-, INTRA- OR POST-OPERATION? WERE CULTURES PERFORMED? IF SO, PLEASE PROVIDE THE RESULTS. PLEASE DESCRIBE ANY MEDICAL INTERVENTION PERFORMED INCLUDING MEDICATION NAME AND RESULTS. 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.
IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2025 AND MESH WAS IMPLANTED. ON (B)(6) 2025, MILD URINARY TRACT INFECTION WAS NOTED. UNSPECIFIED DRUG THERAPY WAS PROVIDED AND THE PATIENT RECOVERED/RESOLVED WITHOUT SEQUELAE AS OF(B)(6) 2025. THIS WAS REPORTED AS NOT RELATED TO THE STUDY DEVICE, BUT POSSIBLE RELATED TO THE STUDY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 165084 | TVT EXACT RETROPUBIC SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC | OTN | ETHICON INC. | 3944950 | 10705031062375 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |