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 SMOOTH ROUND MODERATE PROFILE 3501660 manufactured by Mentor Texas.
[186203709]
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: right breast cancer. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186203710]
It was reported that a (b)(6) year-old hispanic female patient underwent a primary breast augmentation procedure with mentor smooth round moderate profile 375cc saline breast prostheses and suffered several unexplained systemic symptoms, including joint pain, chest pain, back pain, headaches, burning sensation, and right breast pain. No device issue such as rupture was reported. The root cause of the patient? S symptoms is unclear. In addition, a mammogram performed on (b)(6) 2020 confirmed invasive ductal carcinoma (stage 2 cancer) on the right breast. The patient underwent a biopsy and lumpectomy on (b)(6) 2020. The patient reported that she would start chemotherapy on (b)(6) 2020 and is planning to have a double mastectomy with reconstruction. At the time of this report, mentor has received no information regarding explantation or an expected explantation date. This medwatch report is for the patient? S left breast prosthesis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1645337-2020-05098 |
| MDR Report Key | 9906987 |
| Report Source | CONSUMER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-10 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2009-08-27 |
| 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 MODERATE PROFILE |
| Generic Name | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE |
| Product Code | FWM |
| Date Received | 2020-03-31 |
| Model Number | 3501660 |
| Catalog Number | 3501660 |
| Lot Number | 5931841 |
| Device Expiration Date | 2013-08-26 |
| 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 |