MENTOR SMOOTH ROUND MODERATE PROFILE
Report
- Report Number
- 1645337-2018-04024
- Event Type
- Injury
- Date Received
- July 2, 2018
- Date of Event
- April 30, 2018
- Report Date
- June 11, 2018
- Manufacturer
- MENTOR TEXAS
- Product Code
- FWM
- UDI-DI
- 00081317001218
- PMA / PMN Number
- P990075
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL INFORMATION WAS RECEIVED ON 8/16/2018. THE EVENT DATE HAS BEEN UPDATED TO (B)(6) 2018. THE INVESTIGATION OF THE RETURNED PRODUCT WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON 8/29/2018. DEVICE EVALUATION SUMMARY: IT WAS REPORTED THAT A (B)(6) YEAR-OLD UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 250CC SALINE PROSTHESIS, AND A MENTOR SMOOTH ROUND MODERATE PROFILE 225CC SALINE PROSTHESIS ON (B)(6) 2015. BILATERAL DEFLATION WAS DIAGNOSED BY ULTRASOUND POST PROCEDURE. UPON RECEIPT BY MENTOR, THE DEVICE CONTAINED NO FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. DURING VISUAL EXAMINATION OF THE DEVICE, THE PRODUCT EVALUATION TEAM OBSERVED AN AREA OF MISSING MATERIAL ON THE POSTERIOR VIEW MEASURING 2.5CM BY 1.8 CM. AN ADDITIONAL RENT WAS OBSERVED ON THE POSTERIOR VIEW MEASURING 3.8 CM. NO OTHER ANOMALIES WERE FOUND. MENTOR PRODUCTS ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE, IN ADDITION, A THOROUGH IN-PROCESS TESTING DURING SEVERAL STAGES OF THE MANUFACTURING PROCESS IS PERFORMED. THE PRODUCT EVALUATION TEAM CONCLUDED THAT THE MISSING MATERIAL AND RENT OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE COMPLAINT OF DEFLATION WAS CONFIRMED SINCE AN AREA OF MISSING MATERIAL AND A RENT WERE FOUND ON THE DEVICE. NONETHELESS, A MICROSCOPIC EXAMINATION OF THE EDGES OF THE MISSING MATERIAL AND RENT WAS PERFORMED, AND IT DID NOT PROVIDE CONCLUSIVE EVIDENCE OF WHAT COULD BE THE ROOT CAUSE. NO CORRECTIVE ACTION IS REQUIRED SINCE THERE IS NO EVIDENCE THAT THE FAILURES MODES ARE RELATED WITH MANUFACTURING OR PRODUCT DESIGN. 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).
THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 6913915 WAS REVIEWED ON 7/6/2018 AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. 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 DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: MENTOR SMOOTH ROUND MODERATE PROFILE 250CC SALINE PROSTHESIS, CATALOG #3501630, LOT #6784470. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A (B)(6) UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 250CC SALINE PROSTHESIS, AND A MENTOR SMOOTH ROUND MODERATE PROFILE 225CC SALINE PROSTHESIS ON (B)(6) 2015. BILATERAL DEFLATION WAS DIAGNOSED BY ULTRASOUND POST PROCEDURE. AS A RESULT, PROSTHESIS REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PROFILE 250 CC SALINE IMPLANTS WAS PERFORMED ON (B)(6) 2018. (SEE 1645337-2018-04023 FOR CONTRALATERAL PROSTHESIS REPORT).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 497858 | MENTOR SMOOTH ROUND MODERATE PROFILE | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | MENTOR TEXAS | 6913915 | 00081317001218 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Required Intervention |