MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-31 for MENTOR MEMORYGEL BREAST IMPLANT 3503504BC manufactured by Mentor Texas.
[146782002]
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. 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: the patient has not undergone explantation or reoperation at this time. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[146782003]
It was reported that a caucasian female patient underwent a breast augmentation primary with mentor memorygel breast implants 350cc and experienced capsular contracture baker grade unknown on the left side and bilateral nipple numbness. At the time of this report, mentor has received no information regarding explantation or an expected explantation date. This report is for the left side.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1645337-2019-12996 |
| MDR Report Key | 8660847 |
| Report Source | CONSUMER |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-01 |
| Date Mfgr Received | 2019-08-15 |
| Device Manufacturer Date | 2011-04-21 |
| 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 MEMORYGEL BREAST IMPLANT |
| Generic Name | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED |
| Product Code | FTR |
| Date Received | 2019-05-31 |
| Catalog Number | 3503504BC |
| Lot Number | 6467212 |
| Device Expiration Date | 2016-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Other; 2. Required No Informationntervention | 2019-05-31 |