MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for MENTOR MEMORYGEL BREAST IMPLANT 3504004BC manufactured by Mentor Texas.
[185865440]
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 is in progress. Once completed, a supplemental report will be submitted. Reason for device explant and/or reoperation: the patient has not undergone explantation or reoperation at this time. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185865441]
It was reported that a (b)(6) year-old female patient who underwent a breast augmentation primary with 400cc smooth mentor memorygel breast implant has experienced postoperative right-sided capsular contracture (unknown grade) and right-sided lymphadenopathy. Patient reported that the right side consistently gets tight, causing a pulling sensation in the right arm, and lymph nodes are swollen with underarm pain. Patient had a mammogram performed in (b)(6) 2019 with findings of dense breast tissue; patient was diagnosed with possible capsular contracture. At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1645337-2020-05113 |
| MDR Report Key | 9907793 |
| Report Source | CONSUMER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-10 |
| Date of Event | 2019-10-01 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2008-01-26 |
| 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 MEMORYGEL BREAST IMPLANT |
| Generic Name | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED |
| Product Code | FTR |
| Date Received | 2020-03-31 |
| Model Number | 3504004BC |
| Catalog Number | 3504004BC |
| Lot Number | 5799987 |
| Device Expiration Date | 2013-01-24 |
| 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. Other | 2020-03-31 |