ENTOR SMOOTH ROUND HIGH PROFILE
Report
- Report Number
- 1645337-2020-14619
- Event Type
- Injury
- Date Received
- November 16, 2020
- Date of Event
- November 2, 2020
- Report Date
- November 2, 2020
- Manufacturer
- MENTOR TEXAS
- Product Code
- FWM
- UDI-DI
- 00081317001690
- PMA / PMN Number
- P990075
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
ON DECEMBER 10, 2020, THE MENTOR FAILURE ANALYSIS LAB 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 (B)(6) 2020, DEVICE EVALUATION WAS COMPLETED. DEVICE EVALUATION SUMMARY: DURING THE VISUAL EVALUATION, AN ANOMALY WAS OBSERVED ON THE POSTERIOR VIEW OF THE DEVICE CONSISTENT WITH A CREASE/FOLD. A TEAR WAS ALSO OBSERVED WITHIN THE CREASE/FOLD, MEASURING APPROXIMATELY 0.5 CM. THE EVALUATION DETERMINED THAT THE LOSS OF SHELL INTEGRITY IS CONSISTENT WITH A CREASE FOLD DEFLATION OF THE IMPLANT SHELL, WHICH IS A KNOWN INHERENT RISK OF SALINE-FILLED MAMMARY PROSTHESIS. DEFLATION CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. CREATING WRINKLES OR FOLDS SHOULD BE AVOIDED DURING IMPLANTATION OR OTHER PROCEDURES AS IT CAN RESULT IN A DEFLATION IN A LATER TIME. BREAST IMPLANTS MAY ALSO SIMPLY WEAR OUT OVER TIME. A SECOND PRODUCT WAS RECEIVED (PRODUCT CODE 3503630 AND LOT NUMBER 5822771). NO ADVERSE EVENTS WERE REPORTED FOR THIS CONCOMITANT (CONTRALATERAL) DEVICE, THEREFORE NO FURTHER ANALYSIS IS REQUIRED. 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. 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 NOVEMBER 18, 2020, MENTOR BECAME AWARE THAT THE DATE FOR EXPLANT SURGERY IS ON (B)(6) 2020. HENCE, FOLLOWING FIELDS HAVE BEEN UPDATED ON THIS FORM: IS REQUIRED INTERVENTION HAS BEEN SELECTED UNDER SECTION B; FIELD B2. FIELD D7 EXPLANTATION DATE HAS BEEN UPDATED TO ON (B)(6) 2020. FIELD H6 PATIENT CODE "NO CODE AVAILABLE" HAS BEEN ADDED. FIELD H6 METHOD CODE HAS BEEN UPDATED TO "DEVICE NOT RETURNED". H6 PATIENT CODE 3191: MEDICAL DEVICE REMOVAL. 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 MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: AS OF NOW THERE IS NO INFORMATION REGARDING THE EXPLANT OR REOPERATION. (B)(4).
IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 560CC MENTOR SMOOTH ROUND HIGH PROFILE AND EXPERIENCED RIGHT SIDE BREAST IMPLANT DEFLATION. 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 |
|---|---|---|---|---|---|---|---|
| 1312739 | ENTOR SMOOTH ROUND HIGH PROFILE | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | MENTOR TEXAS | 3503560 | 5820982 | 00081317001690 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other| R |