UNKNOWN GEL BREAST PROSTHESIS
Report
- Report Number
- 1645337-2023-10007
- Event Type
- Injury
- Date Received
- August 25, 2023
- Date of Event
- July 25, 2023
- Manufacturer
- MENTOR TEXAS
- Product Code
- FTR
- PMA / PMN Number
- P030053
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ON OCTOBER 02, 2024, MENTOR RECEIVED ADDITIONAL INFORMATION REGARDING THE PATIENT. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A NEW EPISODE OF CELLULITIS ON (B)(6) 2024. THE PATIENT WAS ADMITTED TO A HOSPITAL FOR INTRAVENOUS ANTIBIOTICS. CODE E040203-LOCAL REACTION HAS BEEN ADDED IN SECTION H6-HEALTH EFFECT - CLINICAL CODE TO DOCUMENT THE REPORTED INFORMATION. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE UDI IS NOT AVAILABLE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON MARCH 06, 2025, MENTOR RECEIVED ADDITIONAL INFORMATION REPORTING THAT THE PATIENT UNDERWENT DEVICE EXPLANTATION ON (B)(6) 2025. SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: WOUND INFECTION AND LOCAL REACTION (CELLULITIS). ON MARCH 10, 2025, MENTOR RECEIVED ADDITIONAL INFORMATION REPORTING THAT THE PATIENT'S REPLACEMENT DEVICE WAS A "MENTOR NON-STUDY GEL DEVICE". MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE HAS BEEN RECEIVED. MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON AUGUST 19, 2025, MENTOR RECEIVED ADDITIONAL INFORMATION REGARDING THE PATIENT'S EVENT. IT WAS REPORTED THAT THE PATIENT ALSO EXPERIENCED BREAST PAIN. CODE E1402 HAS BEEN ADDED IN SECTION H6-HEALTH EFFECT - CLINICAL CODE TO DOCUMENT THIS ADDITIONAL INFORMATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL (SUBJECT ID: (B)(6)). IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A REVISION BREAST RECONSTRUCTION WITH AN UNSPECIFIED GEL BREAST PROSTHESIS AND EXPERIENCED A WOUND INFECTION ON THE LEFT SIDE POST-OPERATIVELY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CELLULITIS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 932030 | UNKNOWN GEL BREAST PROSTHESIS | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | MENTOR TEXAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Female | Other| R |