MENTOR SMOOTH ROUND SPECTRUM
Report
- Report Number
- 1645337-2018-01779
- Event Type
- Injury
- Date Received
- March 28, 2018
- Date of Event
- February 26, 2018
- Report Date
- February 28, 2018
- Manufacturer
- MENTOR TEXAS
- Product Code
- FWM
- UDI-DI
- 00081317001997
- PMA / PMN Number
- P990075
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
ON 7/5/2018, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE COMPLAINT DEVICE. AS A RESULT, THE MANUFACTURING DATE AND EXPIRATION DATE FIELDS HAVE BEEN UPDATED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
UPON RECEIPT BY MENTOR, THE DEVICE CONTAINED NO FLUID. BROWN MATERIAL WAS OBSERVED WITHIN THE DEVICE. NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. EVALUATION OF THE DEVICE REVEALED A RENT MEASURING APPROXIMATELY 0.1 CM WITHIN A CREASE ON THE POSTERIOR ASPECT. NO OTHER ANOMALIES WERE DISCOVERED. THE COMPLAINT OF DEFLATION WAS CONFIRMED. MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE, PRODUCT EVALUATION CONCLUDED THAT THE RENT AND CREASE OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. A POSSIBLE CAUSE OF THE FAILURE COULD NOT BE DETERMINED. PTOSIS AND DEFLATION ARE KNOWN COMPLICATIONS ASSOCIATED WITH THESE DEVICES AND ARE REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
THE FOLLOWING INFORMATION WAS MISTAKENLY OMITTED FROM THE SUPPLEMENTAL REPORTS SENT ON 4/27/2018: SUSPECT MEDICAL DEVICE'S LOT NUMBER: 6859455 AND SERIAL NUMBER: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
ON (B)(6) 2018, THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (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 PRODUCTS: MENTOR SMOOTH ROUND SPECTRUM 325CC SALINE, CATALOG #3501450, LOT #6904305 SN #(B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).
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. (B)(4).
IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH MENTOR SMOOTH ROUND SPECTRUM 325CC SALINE BREAST PROSTHESES. DURING A SURGERY FOR POOR COSMETIC RESULTS, THE SURGEON NOTICED THAT THERE WAS BILATERAL DEFLATION. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH UNKNOWN BREAST PROSTHESES ON (B)(6) 2018. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 220839 | MENTOR SMOOTH ROUND SPECTRUM | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | MENTOR TEXAS | 6859455 | 00081317001997 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |