TVT EXACT RETROPUBIC SYSTEM
Report
- Report Number
- 2210968-2022-09443
- Event Type
- Injury
- Date Received
- November 15, 2022
- Date of Event
- June 23, 2022
- Report Date
- November 15, 2022
- 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
- PHYSICIAN
- Health Professional
- Yes
Narratives
(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. 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.
(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: URINARY FREQUENCY. START DATE: 26 AUG 2022. RELATIONSHIP TO STUDY DEVICE: POSSIBLE. RELATIONSHIP TO PRIMARY STUDY PROCEDURE: POSSIBLE. DRUG THERAPY: NO. SURGICAL PROCEDURE, THERAPY, OR INTERVENTION: NO. OUTCOME: UNKNOWN.
(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. ADDITIONAL INFORMATION RECEIVED: ADVERSE EVENT TERM: SUBURETHRAL MESH EROSION. UPDATED: END DATE: BLANK: 20 MAR 2023. SURGICAL PROCEDURE, THERAPY, OR INTERVENTION: NO: YES. SPECIFY: BLANK: EXCISION OF ERODED MESH. OUTCOME: NOT RECOVERED/NOT RESOLVED: RECOVERED/RESOLVED WITHOUT SEQUELAE. ADVERSE EVENT TERM: LEVATOR SPASM. UPDATED: END DATE: BLANK: 20 MAR 2023. OUTCOME: UNKNOWN: RECOVERED/RESOLVED WITHOUT SEQUELAE. ADVERSE EVENT TERM: URINARY FREQUENCY. UPDATED: END DATE: BLANK: 20 MAR 2023. OUTCOME: UNKNOWN: RECOVERED/RESOLVED WITHOUT SEQUELAE.
(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: A3, A4, B7, D1, D4, E1, E3 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, 76.4KG, 31.3 THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? STRESS INCONTINENCE WERE ANY CONCOMITANT PROCEDURES PERFORMED? YES WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? MESH EROSION IS ASYMPTOMATIC OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? YES WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? NOT SURE WHAT THEY ARE ASKING STILL WERE ANY CONCURRENT DEVICES IMPLANTED? YES WERE THERE ANY INTRA-OPERATIVE COMPLICATIONS? NO PLEASE PROVIDE THE MESH EXPOSURE SYMPTOMS AND DIAGNOSTIC CONFIRMATION. ASYMPTOMATIC, DIAGNOSED BY PHYSICAL EXAM DESCRIBE ANY MEDICAL/SURGICAL INTERVENTION FOR THE EXPOSURE INCLUDING DATES AND FINDINGS. -NO INTERVENTION AT THIS TIME WAS THE EXPOSED MESH EXCISED? IF SO, WAS THE REMOVAL PARTIAL OR FULL? NO WERE ANY DEFICIENCIES OR ANOMALIES NOTED WITH MESH DEVICE? NO WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? PER AE CRF ¿ THE RELATIONSHIP TO DEVICE AND STUDY PROCEDURE ARE POSSIBLE WHAT IS THE PATIENT'S CURRENT STATUS? MESH EROSION STILL ASYMPTOMATIC BUT WILL BE TREATED IN THE OR AT THE SAME AS URETHRAL BULKING PRODUCT CODE AND LOT NUMBER? - TVTRL - 3940326
(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 MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH, AND NO NON-CONFORMANCES WERE IDENTIFIED.
(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: PERSISTENT STRESS INCONTINENCE. START DATE: (B)(6) 2022. RELATIONSHIP TO STUDY DEVICE: POSSIBLE. RELATIONSHIP TO PRIMARY STUDY PROCEDURE: POSSIBLE. DRUG THERAPY: NO. SURGICAL PROCEDURE, THERAPY, OR INTERVENTION: NO. OUTCOME: NOT RECOVERED/NOT RESOLVED. ADVERSE EVENT TERM: LEVATOR SPASM. START DATE: (B)(6) 2022. RELATIONSHIP TO STUDY DEVICE: POSSIBLE. RELATIONSHIP TO PRIMARY STUDY PROCEDURE: POSSIBLE. DRUG THERAPY: NO. SURGICAL PROCEDURE, THERAPY, OR INTERVENTION: NO. NON-SURGICAL PROCEDURE, THERAPY, OR INTERVENTION: YES. SPECIFY: REFERRAL TO PELVIC FLOOR PT. OUTCOME: UNKNOWN. ADVERSE EVENT TERM: DYSURIA. OUTCOME: RECOVERED/RESOLVED WITHOUT SEQUELAE . END DATE: (B)(6) 2022.
(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: PERSISTENT STRESS INCONTINENCE UPDATED: SURGICAL PROCEDURE, THERAPY, OR INTERVENTION: YES, SPECIFY: BULKAMID INJECTION, OUTCOME: RECOVERED/RESOLVED WITHOUT SEQUELAE, END DATE:(B)(6) 2023.
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND MESH WAS IMPLANTED. ON (B)(6) 2022, URGENCY INCONTINENCE WAS NOTED AND REPORTED AS POSSIBLY RELATED TO THE STUDY DEVICE AND PROCEDURE. ON (B)(6) 2022, SUBURETHRAL MESH EROSION WAS NOTED AND REPORTED AS A CAUSAL RELATIONSHIP WITH THE STUDY DEVICE AND PROCEDURE. NEITHER THE INCONTINENCE OR EROSION HAS BEEN RECOVERED/RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1020929 | TVT EXACT RETROPUBIC SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC | OTN | ETHICON INC. | TVTRL | 3940326 | 10705031062375 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female | Other |