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 3504504BC manufactured by Mentor Texas.
[146781327]
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 (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: rupture. Concomitant products: mentor memorygel breast implant 450cc, catalog number: 3504504bc, serial number: (b)(4), lot number: 5919040. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[146781332]
It was reported that a (b)(6)-year-old caucasian female patient underwent a breast augmentation revision with a mentor memorygel breast implant 450cc and experienced rupture on the left side and a tingling sensation. A breast mass was found on the left side via mammogram after patient reported a lump to her physician. The patient underwent a core needle biopsy and a breast cyst was discovered. The results were negative for malignancy. As a result, the patient will undergo removal on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1645337-2019-13016 |
| MDR Report Key | 8660764 |
| Report Source | CONSUMER |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-02 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-10-24 |
| Device Manufacturer Date | 2010-05-19 |
| 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 |
| Returned To Mfg | 2019-07-02 |
| Catalog Number | 3504504BC |
| Lot Number | 5992809 |
| Device Expiration Date | 2015-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 |