MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for UNKNOWN SALINE IMPLANTS SMOOTH UNK_SALINE IMPLANTS SMOOTH manufactured by Mentor Texas.
[186206267]
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. Since no lot number was provided, no manufacturing record evaluation could be performed. Reason for device explant and/or reoperation: deflation. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186206268]
It was reported that a (b)(6) year-old caucasian female patient underwent a primary breast augmentation with an unspecified mentor saline smooth breast implant and experienced postoperative right-sided deflation. The patient went in for a consultation on 18-feb-2019, and the diagnosis was confirmed by a healthcare professional. As a result, the patient underwent bilateral removal and replacement with two 525cc mentor smooth round moderate profile prostheses (catalog #: 3501685, right serial #: (b)(4), left serial #: (b)(4) on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1645337-2020-05060 |
| MDR Report Key | 9907391 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-10 |
| Date of Event | 2019-02-18 |
| Date Mfgr Received | 2020-03-10 |
| 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 | UNKNOWN SALINE IMPLANTS SMOOTH |
| Generic Name | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE |
| Product Code | FWM |
| Date Received | 2020-03-31 |
| Catalog Number | UNK_SALINE IMPLANTS SMOOTH |
| 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 |