MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-31 for MENTOR SMOOTH ROUND HIGH PROFILE 3503330 manufactured by Mentor Texas.
[146690662]
The complaint device has been discarded. As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed. 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. Reason for device explant and/or reoperation: deflation. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[146690663]
It was reported that a (b)(6) year old hispanic female patient who underwent primary breast augmentation with two 330cc mentor smooth round high profile saline breast prostheses, experienced right side deflation and left side capsular contracture baker grade iii post-operatively. As a result, the patient underwent bilateral removal and replacement with two 400cc mentor memorygel breast implants on (b)(6) 2019. It was also noted that during explantation, calcification was found around the left implant. This medwatch form is for the right breast prosthesis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1645337-2019-12986 |
| MDR Report Key | 8659562 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-01 |
| Date of Event | 2019-04-12 |
| Date Mfgr Received | 2019-05-01 |
| Device Manufacturer Date | 2005-12-21 |
| Date Added to Maude | 2019-05-31 |
| 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 | 2019-05-31 |
| Catalog Number | 3503330 |
| Lot Number | 5652904 |
| Device Expiration Date | 2009-12-20 |
| 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 | 2019-05-31 |