POSTERIOR PELVIC FLOOR REPAIR
Report
- Report Number
- 2210968-2025-12014
- Event Type
- Injury
- Date Received
- October 17, 2025
- Date of Event
- February 19, 2009
- Manufacturer
- ETHICON INC.
- Product Code
- OTP
- UDI-DI
- 10705031062320
- PMA / PMN Number
- K071512
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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. 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.
DATE SENT TO THE FDA: 4/2/2026. ADDITIONAL INFORMATION: D6A. ADDITIONAL B5 NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON 6/2/2008 AND PROLIFT WAS IMPLANTED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.
DATE SENT TO THE FDA: 3/20/2026 D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. ADDITIONAL INFORMATION: D4 (EXPIRATION, LOT #, PRIMARY UDI #), H4 CORRECTED: D1, D4(CATALOG). ADDITIONAL B5 NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON AN UNKNOWN DATE AND PROLIFT WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON AN (B)(6) 2009. IT WAS REPORTED THAT THE PATIENT UNDERWENT ANOTHER REVISION SURGERY ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED CHRONIC PAIN, TENDERNESS, AND ACHING. NO ADDITIONAL INFORMATION PROVIDE. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. (B)(4) SUBMITTED FOR ADVERSE EVENT WHICH OCCURRED ON 2/19/2009. (B)(4) SUBMITTED FOR ADVERSE EVENT WHICH OCCURRED ON 6/8/2023. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.
DATE SENT TO THE FDA: 4/3/2026. H6: PAIN (E2330) UTILIZED TO CAPTURE CHRONIC PAIN. ADDITIONAL INFORMATION: A1, A3A, G2 (REPORT SOURCE). CORRECTED INFORMATION: D4 (PRIMARY UDI #), E1. CORRECTED (G3) ALERT DATE. THE CORRECT LEGAL AWARENESS/ALERT DATE FOR THIS COMPLAINT IS (03/09/2026) MARCH 9, 2026 BASED ON (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.
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. CORRECTED INFORMATION: B3.
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON AN UNKNOWN DATE AND MESH WAS IMPLANTED. THE PATIENT REPORTED EXPERIENCING SEVERE PAIN AFTERWARDS BECAUSE THE MESH WENT THROUGH THE VAGINA AND RECTUM MAKING IT IMPOSSIBLE TO HAVE SEXUAL INTERCOURSE. THE PATIENT WAS RE-OPERATED IN 2009 WHEN THE MESH WAS SPLIT ACROSS. SINCE THEN THE PATIENT HAS HAD A LOT OF DISCOMFORT FROM THE MESH THAT YOU CAN FEEL IN THE VAGINA AND RECTUM WHICH AFFECTED THE PATIENT BOTH PHYSICALLY AND MENTALLY. FOR SEVERAL YEARS SINCE, THE PATIENT HAS HAD CHRONIC PAIN / PALPABLE TENDERNESS WHEN SITTING AND AT NIGHT THE PATIENT FELT TENSE, PULLING AND ACHING BILATERALLY IN GLUTES, MAKING IT DIFFICULT TO SLEEP. THE PATIENT SOUGHT HELP FROM SEVERAL ORTHOPEDIC SURGEONS AND OTHERS AND HAS BEEN TREATED WITH PHYSICAL THERAPY AND CORTISONE INJECTIONS WITHOUT EFFECT. RESEARCH HAS RULED OUT THAT THE PAIN CAME FROM THE BACK. IN 2023, THE PATIENT HAD A GYN SURGERY, WHICH IS WHEN IT WAS DISCOVERED THAT THE PAIN IS CAUSED BY THE MESH. ATTEMPTS TO REMOVE THE MESH PROVED IMPOSSIBLE AS THE MESH LIES DEEP AND ROLLED UP IN STRONG SCAR TISSUE AND CLOSE TO THE INTESTINE. MRI OF THE LOWER ABDOMEN WAS PERFORMED IN 2024 AND SHOWED THE COINCIDING MESH AND WIDESPREAD FIBROSIS IN THE SMALL PELVIS. AFTER SEVERAL EXAMINATIONS AND NHV - MEETING (NATIONAL HIGH-SPECIALIZED CARE), THEY HAVE CONCLUDED THAT IT IS NOT POSSIBLE TO REMOVE THE MESH DUE TO A HIGH RISK OF FURTHER DAMAGE AND PERMANENT STOMA. NO FURTHER INFORMATION IS AVAILABLE OR COULD BE OBTAINED AS REPORTER DETAILS HAVE NOT BEEN DISCLOSED (CONFIDENTIAL).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 473748 | POSTERIOR PELVIC FLOOR REPAIR | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC | OTP | ETHICON INC. | 3109572 | 10705031062320 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |