MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for MENTOR SMOOTH ROUND HIGH PROFILE 3503250 manufactured by Mentor Texas.
[186352371]
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 manufacturing record evaluation is in progress. Once completed, a supplemental report will be submitted. Reason for device explant and/or reoperation: capsular contracture, baker grade unknown. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186352372]
It was reported that a (b)(6) caucasian female patient underwent a primary breast augmentation with mentor smooth round high profile 250cc and experienced bilateral capsular contracture, baker grade iv (left), and unknown (right) post-operatively, which was confirmed by a physician. As a result, the patient underwent explantation on (b)(6) 2020. This report is for the right side device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1645337-2020-05091 |
| MDR Report Key | 9905531 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2010-09-07 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 3041 SKYWAY CIRCLE NORTH |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal | 75038 |
| Manufacturer Phone | 949789-868 |
| Manufacturer G1 | MENTOR TEXAS |
| Manufacturer Street | 3041 SKYWAY CIRCLE NORTH |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MENTOR SMOOTH ROUND HIGH PROFILE |
| Generic Name | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE |
| Product Code | FWM |
| Date Received | 2020-03-31 |
| Model Number | 3503250 |
| Catalog Number | 3503250 |
| Lot Number | 6408344 |
| Device Expiration Date | 2014-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MENTOR TEXAS |
| Manufacturer Address | 3041 SKYWAY CIRCLE NORTH IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |