MENTOR MEMORYGEL BREAST IMPLANT
Report
- Report Number
- 1645337-2021-12562
- Event Type
- Injury
- Date Received
- November 11, 2021
- Date of Event
- October 8, 2016
- Report Date
- October 21, 2021
- Manufacturer
- MENTOR TEXAS
- Product Code
- FTR
- PMA / PMN Number
- P030053
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
MANUFACTURER¿S REFERENCE NUMBER: (B)(4). ON NOV 16 2021, IT WAS NOTICED THE FOLLOWING INFORMATION WAS ERRONEOUSLY OMITTED FROM THE PREVIOUS REPORT: THE DEVICE WAS IDENTIFIED AS A MENTOR MEMORYGEL BREAST IMPLANT 295CC, CATALOG NUMBER 3505295BC, SERIAL NUMBER (B)(6). A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES.
ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT ALSO EXPERIENCED HYPOTHYROIDISM. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON (B)(6), 2023, SECONDARY/CLINICAL REVIEW WAS PERFORMED. AS A RESULT, H6. HEALTH EFFECT - CLINICAL CODE E1720 HAS BEEN UPDATED TO E040203. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON JUL 12, 2023, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE DERMATITIS OCCURRED ON THE LEFT SIDE. THIS REPORT IS FOR THE LEFT BREAST PROSTHESIS. 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: THE PATIENT HAS NOT UNDERGONE EXPLANTATION OR REOPERATION AT THIS TIME. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A (B)(6) AFRICAN AMERICAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH AN UNSPECIFIED MENTOR GEL BREAST IMPLANT AND EXPERIENCED DERMATITIS ON THE RIGHT SIDE POST-OPERATIVELY. 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 |
|---|---|---|---|---|---|---|---|
| 1694174 | MENTOR MEMORYGEL BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | MENTOR TEXAS | 7335071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Unknown | Other |