MENTOR SMOOTH ROUND MODERATE PROFILE
Report
- Report Number
- 1645337-2018-05360
- Event Type
- Injury
- Date Received
- September 4, 2018
- Date of Event
- October 1, 2010
- Report Date
- August 16, 2018
- Manufacturer
- MENTOR TEXAS
- Product Code
- FWM
- UDI-DI
- 00081317001270
- PMA / PMN Number
- P990075
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
ON (B)(6) 2019, IT WAS REPORTED TO MENTOR THAT THERE WAS RIPPLING ON BREAST IMPLANTS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON (B)(6) 2020, A PHOTO OF THE AFFECTED DEVICES WAS RECEIVED BY MENTOR . MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON (B)(6) 2020, IT WAS ERRONEOUSLY OMITTED TO REPORT THAT THE DEVICES WERE REMOVED, HOWEVER, THE DATE OF EXPLANTATION IS UNKNOWN. IN ADDITION, THE PICTURES WERE RECEIVED ON (B)(6) 2020, THEREFORE, THE DUE DATE OF THE PREVIOUS SUPPLEMENTAL REPORT WAS ACTUALLY (B)(6) 2020 AND THE AWARENESS DATE WAS (B)(6) 2020. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
AFTER CLINICAL REVIEW OF THIS FILE PERFORMED ON 04/20/2020, IT WAS DECIDED TO REMOVE CUTANEOUS CONTOUR DEFORMITY TO MORE ACCURATELY CAPTURE THE REPORTED EVENT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON (B)(6) 2020, DURING VISUAL INSPECTION OF THE DEVICE, NO APPARENT DAMAGE COULD BE OBSERVED. LEAK TESTING REVEALED THERE WAS LEAKAGE FROM THE VALVE. THE ANALYSIS WAS UNABLE TO DETERMINE THE ROOT CAUSE FOR THE LEAKING VALVE. EXCESSIVE MANIPULATION MAY HAVE CAUSED THE VALVE LEAK. THE IFU STATES ¿NOT TO MANIPULATE (I.E., SQUEEZE) THE VALVE EXCESSIVELY, WHICH MAY CAUSE VALVE LEAKAGE¿. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. ASYMMETRY MAY BE ATTRIBUTED TO ONE OR MORE OF THE FOLLOWING: CONTRACTURE OF THE FIBROUS CAPSULE, SEROMA OR HEMATOMA, DEVELOPMENT OF POSTOPERATIVE BREAST DYSPLASIA, UNILATERAL DISCREPANCY IN MUSCLE DEVELOPMENT, DEFLATION OF THE IMPLANT, INCORRECT CHOICE OF IMPLANT SHAPE OR SIZE, AND SURGICAL TECHNIQUE. ASYMMETRY IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. COMPLAINT INFORMATION WILL BE INCLUDED IN COMPLAINT TRENDING THAT IS REVIEWED AND MONITOR BY QUALITY ASSURANCE ON A REGULAR BASIS TO DETERMINE IF FURTHER ACTION IS NECESSARY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 1/28/2020, IT WAS REPORTED TO MENTOR THAT THE PATIENT IS PLANNING ON EXPLANTING THE IMPLANTS. THE DATE OF EXPLANTATION IS UNKNOWN. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON (B)(6) 2020, THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. THE DATE OF REMOVAL WAS (B)(6) 2020. ON (B)(6) 2020, DURING VISUAL INSPECTION OF THE DEVICE IT WAS OBSERVED WITH NO APPARENT DAMAGE. LEAK TESTING REVEALED THERE WAS LEAKAGE FROM THE VALVE. THE ANALYSIS WAS UNABLE TO DETERMINE THE ROOT CAUSE FOR THE LEAKING VALVE. EXCESSIVE MANIPULATION MAY HAVE CAUSED THE VALVE LEAK. THE IFU STATES ¿NOT TO MANIPULATE (I.E., SQUEEZE) THE VALVE EXCESSIVELY, WHICH MAY CAUSE VALVE LEAKAGE¿. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. COMPLAINT INFORMATION WILL BE INCLUDED IN COMPLAINT TRENDING THAT IS REVIEWED AND MONITOR BY QUALITY ASSURANCE ON A REGULAR BASIS TO DETERMINE IF FURTHER ACTION IS NECESSARY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 4/24/2020, DURING VISUAL EVALUATION OF THE SAMPLE NO APPARENT DAMAGE WAS OBSERVED. LEAK TESTING WAS PERFORMED IN ACCORDANCE WITH MENTOR'S PROCEDURES. FINDINGS REVEALED A LEAK FROM THE VALVE. ACCORDING WITH THE PRODUCT INSERT DATA SHEET, THE VALVE SYSTEM CAN BE DAMAGED BY IMPROPER USE OF THE FILL-TUBE STYLET. CARE SHOULD BE TAKEN THAT THE STYLET ENTERS THE VALVE SMOOTHLY. USE THE THUMB AND FOREFINGER TO STABILIZE/SUPPORT THE VALVE SEAT AND GENTLY PUSH THE STYLET TIP INTO THE VALVE OPENING. OVERSTRESSING THE VALVE MATERIAL MAY RESULT IN PUNCTURES OR TEARS AND SUBSEQUENT DEFLATION MAY OCCUR. USE ONLY THE FILL TUBE STYLET PROVIDED WITH THIS PRODUCT. TAKE CARE NOT TO PUNCTURE THE DIAPHRAGM VALVE OR THE SHELL WITH THE STYLET TIP. CARE MUST ALSO BE TAKEN WHEN THE FILL TUBE STYLET IS REMOVED TO PREVENT DAMAGE TO THE VALVE ASSEMBLY. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS 5883940 LOT-SERIAL NUMBER WERE REVIEWED AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS LOT. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. DEFLATION COMPLAINT INFORMATION IS CONSISTENTLY ANALYZED AND MONITORED BY QUALITY ASSURANCE TO DETERMINE WHEN FURTHER ACTION IS NECESSARY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 2/25/2020, IT WAS REPORTED TO MENTOR THAT THE PATIENT EXPERIENCED BILATERAL BREAST PTOSIS. THE PATIENT EXPERIENCED DISSATISFACTION WITH BREAST SIZE. THE PATIENT HAS A HISTORY OF MASTODYNIA BILATERALLY. THE REPLACEMENT IMPLANTS WERE MENTOR SMOOTH SALINE 375CC FILLED TO 450CC IMPLANTS. 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 375CC , CATALOG NUMBER 3501660, SERIAL NUMBER (B)(4), LOT NUMBER 5883940. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON (B)(6) 2018, IT WAS REPORTED TO MENTOR THAT THE DATE PROBLEM OBSERVED WAS (B)(6) 2010. (B)(4).
IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 375CC AND EXPERIENCED BILATERAL DEFLATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE RIGHT BREAST IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 683878 | MENTOR SMOOTH ROUND MODERATE PROFILE | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | MENTOR TEXAS | 3501660 | 5883940 | 00081317001270 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Other |