MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-03-16 for UNKNOWN SALINE IMPLANTS manufactured by Mentor Texas.
[102705842]
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 device history record (dhr) review could be performed. Concomitant products: mentor saline implantmanufacturer? S reference number:(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[102705843]
It was reported that a (b)(6) -year old female patient underwent breast augmentation revision with mentor saline breast prostheses. Bilateral deflation was determined. As a result, the patient underwent bilateral removal and replacement with mentor memoryshape breast implant 330cc gel breast prostheses on (b)(6) 2017. This medwatch form is for the left breast prosthesis.
Patient Sequence No: 1, Text Type: D, B5
[134201446]
The mentor failure analysis lab has received the device for evaluation. The analysis has begun, but is not complete at this time. When the investigational analysis has been completed, a supplemental report will be submitted. Concomitant medical products: mentor siltex contour profile moderate 275cc saline, catalog #3542912, lot #5865822. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1645337-2018-01568 |
| MDR Report Key | 7347258 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-03-16 |
| Date of Report | 2018-02-16 |
| Date of Event | 2017-02-22 |
| Date Mfgr Received | 2018-02-16 |
| Device Manufacturer Date | 2009-07-01 |
| Date Added to Maude | 2018-03-16 |
| 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 |
| Generic Name | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE |
| Product Code | FMW |
| Date Received | 2018-03-16 |
| Catalog Number | UNKNOWN SALINE IMPLANTS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-03-16 |