MENTOR SILTEX ROUND MODERATE PROFILE
Report
- Report Number
- 1645337-2018-01993
- Event Type
- Injury
- Date Received
- April 4, 2018
- Date of Event
- March 7, 2018
- Report Date
- March 7, 2018
- Manufacturer
- MENTOR TEXAS
- Product Code
- FWM
- UDI-DI
- 00081317001775
- PMA / PMN Number
- P990075
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE. BROWN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. PRODUCT EVALUATION DISCOVERED A RENT MEASURING APPROXIMATELY 2.3 CM WITHIN AN AREA OF MISSING MATERIAL MEASURED APPROX. 1 CM X 0.5 CM LOCATED ON THE ANTERIOR ASPECT. NO OTHER ANOMALIES WERE DISCOVERED. BECAUSE THE AUTHORIZATION FOR RETURN AND EXAMINATION OF MEDICAL DEVICE FORM WAS NOT SIGNED AND/OR RETURNED TO MENTOR, PRODUCT EVALUATION WAS PRECLUDED FROM FURTHER EVALUATING THE DEVICE. THE COMPLAINT WAS CONFIRMED SINCE A RUPTURE WAS FOUND ON THE DEVICE. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE. THE DHR WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 6/26/2019, MENTOR BECAME AWARE THAT THE CORRECT DATE OF IMPLANTATION OF THE SUSPECT MEDICAL DEVICES WAS (B)(6) 2009. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON (B)(6) 2018, MENTOR BECAME AWARE THAT THE PATIENT ALSO EXPERIENCED DEFLATION ON THE CONCOMITANT DEVICE, MENTOR SILTEX ROUND MODERATE PROFILE 275CC SALINE CATALOG: 3542640 LOT: 5844280 SN: (B)(4). MENTOR ALSO BECAME AWARE THAT THE CORRECT DATE OF IMPLANTATION WAS 2009. ON (B)(6) 2018, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE COMPLAINT DEVICE. AS A RESULT, THE MANUFACTURING DATE AND EXPIRATION DATE FIELDS HAVE BEEN UPDATED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MENTOR ALSO BECAME AWARE THAT THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH (RIGHT) MENTOR MEMORYGEL BREAST IMPLANT 400CC GEL CATALOG: 3504001BC LOT: 7430194 SN: (B)(4) AND (LEFT) MENTOR MEMORYGEL BREAST IMPLANT 375CC GEL CATALOG: 3503751BC LOT: 7568866 SN: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 10/16/2018, MENTOR BECAME AWARE THAT THE CORRECT SERIAL NUMBER FOR THE REPLACEMENT DEVICE FOR THE RIGHT SIDE WAS (B)(4). 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. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: MENTOR SILTEX ROUND MODERATE PROFILE 275CC SALINE CATALOG #3542640 LOT #5844280 SN #(B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 6/1/2018, THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT THAT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SILTEX ROUND MODERATE PROFILE 275CC SALINE BREAST PROSTHESES. THE PATIENT NOTICED RIGHT BREAST PROSTHESIS DEFLATION WHEN THEY WOKE UP. 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 |
|---|---|---|---|---|---|---|---|
| 238469 | MENTOR SILTEX ROUND MODERATE PROFILE | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | MENTOR TEXAS | 5890841 | 00081317001775 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Other| R |