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 3501635 manufactured by Mentor Texas.
[185764961]
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 is in progress. Once completed, a supplemental report will be submitted. Reason for device explant and/or reoperation: capsular contracture baker grade iii and generalized illness. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185764962]
It was reported that a (b)(6) year-old caucasian female patient who underwent primary breast augmentation surgery with two 250cc mentor smooth round moderate profile saline breast implants experienced bilateral capsular contracture baker grade iii, fatigue, brain fog, joint pain, hair loss, dry skin, dry hair, weight gain, heat intolerance, hormone imbalance, insomnia, heart palpitations, neck pain, back pain, edema, swelling, liver dysfunction, kidney dysfunction, digestive issues and hypothyroid hypo-adrenal issues post procedure. As a result, patient underwent bilateral removal with no replacements on (b)(6) 2019. This medwatch form is for the right breast prosthesis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1645337-2020-05076 |
| MDR Report Key | 9904458 |
| 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 | 2012-10-02 |
| 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 | 3501635 |
| Catalog Number | 3501635 |
| Lot Number | 6636585 |
| Device Expiration Date | 2016-09-30 |
| 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 |