MENTOR SMOOTH ROUND MODERATE PROFILE
Report
- Report Number
- 1645337-2018-05280
- Event Type
- Injury
- Date Received
- August 29, 2018
- Date of Event
- June 25, 2018
- Report Date
- August 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
ON 09/21/2018, IT WAS REPORTED TO MENTOR THAT 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. IN ADDITION, THE PATIENT EXPERIENCED CAPSULAR CONTRACTURE BAKER GRADE IV ON THE LEFT BREAST IMPLANT ON (B)(6) 2018. THE PATIENT EXPERIENCED PAIN AND DISCOMFORT. THE PATIENT ALSO EXPERIENCED PAIN ON THE BACK. (B)(4).
ON 10/10/18, IT WAS REPORTED TO MENTOR THAT THE DEVICE EVALUATION AND INVESTIGATION HAVE BEEN COMPLETED. UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. WHITE MATERIAL WAS OBSERVED WITHIN THE DEVICE. NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. UPON INITIAL INSPECTION, THE DEVICE APPEARS INTACT. NO OTHER ANOMALIES WERE DISCOVERED. BECAUSE THE AUTHORIZATION FOR RETURN AND EXAMINATION OF MEDICAL DEVICE FORM WAS NOT SIGNED AND/OR RETURNED TO MENTOR, MENTOR PRODUCT ANALYSIS LAB WAS PRECLUDED FROM FURTHER EVALUATING THE DEVICE. THE COMPLAINT WAS NOT CONFIRMED FOR DEFLATION. AT THIS POINT IS NOT POSSIBLE TO DETERMINE THE ETIOLOGY OF THE WHITE MATERIAL FOUND ON THE DEVICE. CAPSULAR CONTRACTURE IS THE RESULT OF THE BODY¿S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. THE SEVERITY LEVEL FOR THIS COMPLAINT CODE WAS DETERMINED TO BE A S3, WHICH IS DEFINED AS: NECESSITATES INTRUSIVE MEDICAL OR SURGICAL INTERVENTION. BECAUSE MENTOR PRODUCT ANALYSIS LAB WAS UNABLE TO CONFIRM ANY UNUSUAL FAILURE MODE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 10/10/2018, IT WAS REPORTED TO MENTOR THAT THE PATIENT HAD BEEN DIAGNOSED WITH BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV ON (B)(6) 2018. THE DATE PROBLEM OBSERVED WAS (B)(6) 2018. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 10/18/18, IT WAS REPORTED TO MENTOR THAT THE DEVICE EVALUATION AND INVESTIGATION HAVE BEEN COMPLETED. UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. WHITE MATERIAL WAS OBSERVED WITHIN THE DEVICE. NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. UPON INITIAL INSPECTION, THE DEVICE APPEARS INTACT. LEAK TESTING WAS PERFORMED IN ACCORDANCE WITH MENTOR PROCEDURES AND NO LEAK SITES WERE DETECTED. NO OTHER ANOMALIES WERE DISCOVERED. THE COMPLAINT WAS NOT CONFIRMED FOR DEFLATION. AT THIS POINT IS NOT POSSIBLE TO DETERMINE THE ETIOLOGY OF THE WHITE MATERIAL FOUND ON THE DEVICE. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. CAPSULAR CONTRACTURE IS THE RESULT OF THE BODY¿S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. THE SEVERITY LEVEL FOR THIS COMPLAINT CODE WAS DETERMINED TO BE A S3, WHICH IS DEFINED AS: NECESSITATES INTRUSIVE MEDICAL OR SURGICAL INTERVENTION. BECAUSE MENTOR PRODUCT ANALYSIS LAB WAS UNABLE TO CONFIRM ANY UNUSUAL FAILURE MODE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON (B)(6) 2018, IT WAS REPORTED TO MENTOR THAT THE DATE OF EXPLANTATION IS (B)(6) 2018. THE REPLACEMENT PRODUCTS WERE GEL MENTOR MEMORYGEL BREAST IMPLANT 400CC, CATALOG NUMBER 3504004BC, SERIAL NUMBER (B)(4), LOT NUMBER 7007691 ON THE LEFT BREAST IMPLANT AND WITH GEL MENTOR MEMORYGEL BREAST IMPLANT 400CC, CATALOG NUMBER 3504004BC, SERIAL NUMBER (B)(4), LOT NUMBER 7281449 ON THE RIGHT BREAST IMPLANT. 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. 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. CONCOMITANT PRODUCTS: SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 425 CC, CATALOG NUMBER 3501670 , SERIAL (B)(4), LOT NUMBER 5864204. (B)(4).
IT WAS REPORTED THAT A (B)(6) HISPANIC FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 425 CC AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT. 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 |
|---|---|---|---|---|---|---|---|
| 666812 | MENTOR SMOOTH ROUND MODERATE PROFILE | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | MENTOR TEXAS | 5868484 | 00081317001287 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other |