MENTOR SMOOTH ROUND MODERATE PLUS PROFILE
Report
- Report Number
- 1645337-2018-01031
- Event Type
- Injury
- Date Received
- February 22, 2018
- Date of Event
- December 19, 2017
- Report Date
- March 27, 2018
- Manufacturer
- MENTOR TEXAS
- Product Code
- FWM
- UDI-DI
- 00081317001478
- PMA / PMN Number
- P990075
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
ON 07/23/18, IT WAS REPORTED TO MENTOR THAT THE DATE OF EXPLANTATION WAS (B)(6) 2018. THE DATE PROBLEM OBSERVED WAS (B)(6) 2018. THE REPLACEMENT DEVICES WERE SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 500CC. IN ADDITION, 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 09/01/18, IT WAS REPORTED TO MENTOR THAT THE DEVICE EVALUATION AND INVESTIGATION HAVE BEEN COMPLETED. UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. PRODUCT EVALUATION TEAM DISCOVERED A RENT MEASURING APPROXIMATELY 0.2 CM WITHIN A CREASE ON THE POSTERIOR ASPECT. NO OTHER ANOMALIES WERE DISCOVERED. 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. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. BECAUSE PRODUCT EVALUATION TEAM 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 10/11/2018, IT WAS REPORTED TO MENTOR THAT THE RIGHT BREAST IMPLANT WAS INTACT. THE HEALTHCARE PROFESSIONAL NOTICED A LEAK ON THE POSTERIOR WALL ASSOCIATED WITH THE CREASE ON THE LEFT BREAST IMPLANT. THE CAPSULE HAD MINIMAL CONTRACTURE. THE REPLACEMENT DEVICES WERE SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 500CC, FILLED TO 600CC CATALOG NUMBER 3502500, SERIAL NUMBER (B)(4), LOT NUMBER 7549758 ON THE RIGHT BREAST IMPLANT AND SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 500CC, FILLED TO 600CC , CATALOG NUMBER 3502500, SERIAL NUMBER (B)(4), LOT NUMBER 7549758 ON THE LEFT BREAST IMPLANT. THE PATIENT WAS IN A SATISFACTORY CONDITION AFTER THE SURGERY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON (B)(6) 2018, IT WAS REPORTED TO MENTOR THAT THE DEVICE EVALUATION AND INVESTIGATION HAVE BEEN COMPLETED. UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. PRODUCT EVALUATION TEAM DISCOVERED A RENT MEASURING APPROXIMATELY 0.2 CM WITHIN A CREASE ON THE POSTERIOR ASPECT. NO OTHER ANOMALIES WERE DISCOVERED. 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. 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 PRODUCT EVALUATION TEAM WAS UNABLE TO CONFIRM ANY UNUSUAL FAILURE MODE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. 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 PRODUCTS: MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 500CC, CATALOG NUMBER 3502500, SERIAL NUMBER (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON (B)(6) 2018, IT WAS REPORTED TO MENTOR THAT THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 6802940 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. (B)(4).
ON 08/08/18, IT WAS REPORTED THAT THE DATE PROBLEM OBSERVED THAT WAS ORIGINALLY REPORTED AS 12/19/2017 WAS CORRECT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A (B)(6) -YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 500CC BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT. THE COMPLETE DEFLATION OF THE LEFT SIDE BREAST IMPLANT WAS DIAGNOSED BY PHYSICAL EXAM BY A HEALTHCARE PROFESSIONAL. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING AN EXPECTED EXPLANTATION DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 131652 | MENTOR SMOOTH ROUND MODERATE PLUS PROFILE | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | MENTOR TEXAS | 6802940 | 00081317001478 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other |