MENTOR SMOOTH ROUND MODERATE PROFILE
Report
- Report Number
- 1645337-2018-03388
- Event Type
- Injury
- Date Received
- June 1, 2018
- Date of Event
- May 10, 2018
- Report Date
- May 10, 2018
- Manufacturer
- MENTOR TEXAS
- Product Code
- FWM
- UDI-DI
- 00081317001287
- PMA / PMN Number
- P990075
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 5771452 WAS REVIEWED ON 6/2/2018 AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON (B)(6) 2018, MENTOR BECAME AWARE THAT THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2018. 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. (B)(4).
THE INVESTIGATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON 10/28/2018. IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE UNDERWENT BREAST RECONSTRUCTION REVISION WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 425CC SALINE PROSTHESIS. ON (B)(6) 2018, LEFT DEFLATION WAS OBSERVED. THE DEVICE WAS RECEIVED WITH NO FLUID. WHITE MATERIAL WAS OBSERVED WITHIN THE DEVICE AND ON THE SHELL SURFACE. DURING THE INITIAL EVALUATION THE DEVICE APPEARED INTACT. LEAK TESTING OF THE DEVICE, PERFORMED IN ACCORDANCE WITH MENTOR PROCEDURES, REVEALED NO LEAKAGE SITES. NO ANOMALIES WERE DISCOVERED. THE COMPLAINT WAS NOT CONFIRMED. MENTOR PRODUCTS ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE IN ADDITION TO THOROUGH IN-PROCESS TESTING DURING SEVERAL STAGES OF THE MANUFACTURING PROCESS. A ROOT CAUSE FAILURE ANALYSIS WILL NOT BE CONDUCTED SINCE THE INVESTIGATION OF THE REPORTED FAILURE COULD NOT CONFIRM THAT AN ACTUAL FAILURE OF THE DEVICE TO CONFORM TO EXPECTED PERFORMANCE HAD OCCURRED. AT THIS TIME IS NOT POSSIBLE TO DETERMINE THE ORIGIN OF THE WHITE MATERIAL OBSERVED. BECAUSE MENTOR PRODUCT ANALYSIS LAB WAS UNABLE TO CONFIRM ANY UNUSUAL FAILURE MODE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES AND DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. (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. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: MENTOR SMOOTH ROUND MODERATE PROFILE 425CC SALINE PROSTHESIS, CATALOG #3501670, SERIAL #(B)(4).
IT WAS REPORTED THAT A (B)(6) -YEAR-OLD CAUCASIAN FEMALE UNDERWENT BREAST RECONSTRUCTION REVISION WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 425CC SALINE PROSTHESIS. ON (B)(6) 2018, LEFT DEFLATION WAS OBSERVED. 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 |
|---|---|---|---|---|---|---|---|
| 404569 | MENTOR SMOOTH ROUND MODERATE PROFILE | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | MENTOR TEXAS | 5771452 | 00081317001287 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Other| R |