MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-05 for UNKNOWN TISSUE EXPANDERS manufactured by Mentor Texas.
[141113232]
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. Since no lot number was provided, no device history record (dhr) review could be performed. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[141113233]
It was reported that a patient had an unknown mentor tissue expander implanted and experienced deflation. At the time of this report, mentor has received no information regarding explantation or an expected explantation date. No additional information is available at this time. If additional information is made available in the future a supplemental will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1645337-2019-10010 |
| MDR Report Key | 8489185 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-05 |
| Date of Report | 2019-03-13 |
| Date of Event | 2018-12-01 |
| Date Mfgr Received | 2019-03-13 |
| Date Added to Maude | 2019-04-05 |
| 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 TISSUE EXPANDERS |
| Generic Name | EXPANDER, SKIN, INFLATABLE |
| Product Code | LJC |
| Date Received | 2019-04-05 |
| 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. Other | 2019-04-05 |