MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-14 for UNKNOWN TISSUE EXPANDERS UNK_TISSUE EXPANDERS manufactured by Mentor Texas.
[183547449]
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. The lot number reported could not be associated to any products; therefore, no manufacturing record evaluation could be performed. Reason for device explant and/or reoperation: breast cancer. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183547450]
It was reported that a female patient underwent breast implant reconstruction surgery with an unspecified mentor tissue expander and has experienced left breast cancer. The patient underwent exchange of the device on (b)(6) 2019 with replacement to a mentor memorygel breast implant 700cc, catalog number 3507001bc, serial number (b)(4) (l) and a mentor memorygel breast implant 190cc, catalog number 3507190mc, serial number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1645337-2020-04191 |
| MDR Report Key | 9832776 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-14 |
| Date of Report | 2020-02-13 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-03-14 |
| 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 | LCJ |
| Date Received | 2020-03-14 |
| Catalog Number | UNK_TISSUE EXPANDERS |
| Lot Number | 31877197 |
| 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 | 2020-03-14 |