MENTOR SMOOTH ROUND MODERATE PROFILE
Report
- Report Number
- 1645337-2021-09809
- Event Type
- Injury
- Date Received
- September 2, 2021
- Date of Event
- June 24, 2021
- Report Date
- August 13, 2021
- Product Code
- FWM
- PMA / PMN Number
- P990075
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
ON SEPTEMBER 20, 2021, MENTOR BECAME AWARE WITH PAPERWORK RECEIVED WITH THE DEVICE THAT PATIENT ALSO EXPERIENCED RIGHT SIDE WOUND INFECTION AS PER THE INFORMATION, RIGHT SIDE IMPLANT WAS DAMAGED AND INFECTED.THIS SUPPLEMENTAL MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.MANUFACTURER¿S REFERENCE NUMBER:(B)(4)
ON (B)(6) 2021, MENTOR BECAME AWARE OF THE IMPACTED DEVICE INFORMATION. HENCE, FOLLOWING FIELDS HAVE BEEN UPDATED ON THIS FORM: FIELD D1 FOR BRAND NAME HAS BEEN UPDATED TO "MENTOR SMOOTH ROUND MODERATE PROFILE." FIELD D4 FOR CATALOG NUMBER HAS BEEN UPDATED TO "3501650." FIELD D4 FOR LOT NUMBER HAS BEEN UPDATED TO "6881083." FIELD D4 FOR UNIQUE IDENTIFIER( UDI) HAS BEEN UPDATED TO (B)(4)." FIELD G4 FOR PMA/ 510(K) HAS BEEN UPDATED TO "P990075." A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS SUPPLEMENTAL MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON SEPTEMBER 20, 2021, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. ON SEPTEMBER 23, 2021, DEVICE EVALUATION WAS COMPLETED. DEVICE EVALUATION SUMMARY: MENTOR CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. DURING VISUAL EVALUATION, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED ON THE SAL SMOOTH RND DIAP 325CC RETURNED DEVICE. MENTOR CONCLUDED THAT THE CAPSULAR CONTRACTURE IN THE PATIENT¿S BREAST WAS THE RESULT OF THE BODY¿S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. CAPSULAR CONTRACTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. THE AMERICAN SOCIETY OF PLASTIC SURGEONS RECOMMENDS AND ENCOURAGES MEMBER SURGEONS TO ALWAYS SUBMIT BREAST IMPLANTS, CAPSULE, AND EFFUSION TO PATHOLOGY FOR EXAMINATION. 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. THIS SUPPLEMENTAL MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE. 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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: LEFT CAPSULAR CONTRACTURE; BAKER GRADE IV, AND CHEST INJURY. (B)(4).
IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH A 325CC UNKNOWN SALINE IMPLANTS ON BOTH SIDES AND EXPERIENCED LEFT SIDE CAPSULAR CONTRACTURE; BAKER GRADE IV, AND RIGHT SIDE DEFLATION POSTOPERATIVELY. THE DIAGNOSIS WAS CONFIRMED VIA CT SCAN. IT WAS REPORTED THAT THE PATIENT WAS IN A CAR ACCIDENT. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL SURGERY ON (B)(6) 2021. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT-SIDED DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1309854 | MENTOR SMOOTH ROUND MODERATE PROFILE | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | 6881083 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |