MENTOR SMOOTH ROUND HIGH PROFILE
Report
- Report Number
- 1645337-2019-21985
- Event Type
- Injury
- Date Received
- October 17, 2019
- Date of Event
- September 4, 2019
- Report Date
- September 17, 2019
- Manufacturer
- MENTOR TEXAS
- Product Code
- FWM
- PMA / PMN Number
- P990075
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
THE FOLLOWING STATEMENTS WERE ADDED TO THE DEVICE EVALUATIONS PREVIOUSLY SUBMITTED WITH ADDITIONAL ANALYSIS FOR THE ADDITIONAL INFORMATION OF FOREIGN MATTER REPORTED: THE DEVICE WAS VISUALLY INSPECTED AND NO FOREIGN MATTER WAS FOUND ON THE SHELL OR FLOATING INSIDE THE IMPLANT. THE MENTOR MICROBIOLOGY DEPARTMENT HAS PROVIDED INFORMATION ON THE STERILITY LOT FOR THE IMPLANTED DEVICE INDICATING THAT IT MET ALL STERILIZATION PARAMETERS REQUIRED TO PROVIDE STERILITY ASSURANCE PRIOR TO RELEASE FOR DISTRIBUTION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ADDITIONAL INFORMATION WAS RECEIVED ON 1/13/2020. GREEN/WHITE FLOATIES WERE SAID TO BE PRESENT IN THE DEVICES WHEN THEY WERE INSPECTED AFTER EXPLANT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
THE INVESTIGATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON12/23/2019. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, IT WAS REPORTED A PATIENT THAT EXPERIENCED NUMEROUS UNEXPLAINED HEALTH CONDITIONS, INCLUDING BREAST PAIN. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 5962771 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE DEVICE WAS VISUALLY INSPECTED AND NO APPARENT DAMAGE. NO ADDITIONAL ANOMALIES WERE OBSERVED. AN INVESTIGATION OF THE RETURNED DEVICE WAS PERFORMED, AND MENTOR COULD NOT UNCOVER A DEVICE FAILURE THAT WE COULD CONNECT TO THE REPORTED MEDICAL SYMPTOMS. 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. BASED ON THE INFORMATION REPORTED AND/OR THE PRODUCT INVESTIGATION, THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH THE MANUFACTURING PROCESS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ADDITIONAL INFORMATION WAS RECEIVED ON 11/13/2019. THE DEVICE WAS EXPLANTED ON (B)(6) 2019. IS OTHER SERIOUS-CHECK, IS REQUIRED INTERVENTION- CHECK. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: GENERALIZED ILLNESS. THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON (B)(6) 2019. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE PRODUCT, PREVIOUSLY REPORTED AS UNKNOWN GEL, WAS REVEALED UPON RECEIPT BY MENTOR. THE IMPACTED PRODUCT WAS A MENTOR SMOOTH ROUND HIGH PROFILE 380CC SALINE PROSTHESIS. SECTION D HAS BEEN POPULATED WITH ALL NEWLY AVAILABLE DEVICE INFORMATION. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: N/A. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A (B)(6) FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION DUE TO PREVIOUS IMPLANT RUPTURE WITH UNKNOWN MENTOR GEL IMPLANTS EXPERIENCED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS POST PROCEDURE. BREAST PAIN, FATIGUE, JOINT PAIN, STOMACH ISSUES, HYPERTROPHY, LOW BACK PAIN, CERVICALGIA, DORSALGIA, AND UNSPECIFIED FEELINGS OF ILLNESS WERE ALL NOTED. THE PATIENT SUSPECTED BREAST IMPLANT ILLNESS. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEE 1645337-2019-21986 FOR CONTRALATERAL PROSTHESIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 997981 | MENTOR SMOOTH ROUND HIGH PROFILE | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | MENTOR TEXAS | 5962771 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Other| R |