MENTOR SMOOTH ROUND MODERATE PLUS PROFILE
Report
- Report Number
- 1645337-2019-17590
- Event Type
- Injury
- Date Received
- August 21, 2019
- Date of Event
- July 24, 2019
- Report Date
- July 25, 2019
- Manufacturer
- MENTOR TEXAS
- Product Code
- FWM
- UDI-DI
- 00081317001461
- PMA / PMN Number
- P990075
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
ON 10/30/2019, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: DURING EVALUATION OF THE DEVICE IT WAS OBSERVED A CREASE IN POSTERIOR VIEW, ADDITIONALLY A TEAR WITHIN THE CREASE WAS NOTED, MEASURING APPROXIMATELY 0.4 CM. NO OTHER ANOMALIES WERE OBSERVED. THE SECOND PRODUCT RECEIVED IS RELATED TO A CONCOMITANT DEVICE, THERE ARE NEITHER DEFICIENCIES ALLEGED NOR PATIENT INJURIES. THEREFORE NO FURTHER INVESTIGATION IS REQUIRED. THESE KIND OF FINDINGS ARE CONSISTENT WITH A CREASE/FOLD FAILURE WHICH IS A KNOWN INHERENT RISK ASSOCIATED WITH THE USE OF SALINE-FILLED MAMMARY PROSTHESES AND MAY BE THE RESULT OF ONE OR MORE OF THE FOLLOWING CONTRIBUTING FACTORS: UNDER-INFLATION OR OVER-INFLATION OF THE DEVICE, CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE - SUCH AS TOO SMALL A BREAST POCKET AND FOLDING OR WRINKLING OF THE SHELL IN THE BREAST POCKET, RESULTING IN A TEAR AT A LATER DATE. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON 10/3/2019, MENTOR BECAME AWARE THAT THE PATIENT HAD UNDERGONE BILATERAL REMOVAL AND REPLACEMENT WITH THE FOLLOWING DEVICES: (RIGHT) 650CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE CATALOG: 3502650 LOT: 7657198 SN: (B)(4) AND (LEFT) 650CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE CATALOG: 3502650 LOT: 7625035 SN: (B)(4). ON 10/14/2019, 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).
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. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. CONCOMITANT MEDICAL PRODUCTS: (LEFT) 475 CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE CATALOG: 3502475, LOT: 6910927, SN: (B)(4). (B)(4).
IT WAS REPORTED THAT A (B)(6)-YEAR OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 475 CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES, SUFFERED RIGHT SIDE DEFLATION POST-OPERATIVELY. AS A RESULT, THE PATIENT WAS SCHEDULED FOR IMPLANT EXPLANTATION ON (B)(6) 2019.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 710750 | MENTOR SMOOTH ROUND MODERATE PLUS PROFILE | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | MENTOR TEXAS | 7331198 | 00081317001461 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention |