MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-10 for MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS TABS 450CC 3549213 manufactured by Mentor Texas.
[185512142]
The complaint device has been discarded. As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed. A manufacturing record evaluation is in progress. Once completed, a supplemental report will be submitted. Reason for device explant and/or reoperation: deflation manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185512143]
It was reported that a (b)(6) year-old female patient underwent a breast reconstruction primary with mentor cpx 4 breast tissue expander with suture tabs, 450cc saline breast implants which the left side deflated intraoperatively. The report indicated that the implant after injection of 40 ml of saline solution with 2% patent blue, they observed leakage of the solution through the posterior part of the implant. They removed the expander and observed that it had a leak coming from the posterior part, more precisely in its upper medial region. As a result they substitute the right side which was mentor brand lot#: 7467965, sn#: (b)(4), cat#: 3549212 since there was no other expander with desire volume.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1645337-2020-03887 |
| MDR Report Key | 9810768 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-10 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-01-23 |
| Date Added to Maude | 2020-03-10 |
| 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 CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS TABS 450CC |
| Generic Name | EXPANDER, SKIN, INFLATABLE |
| Product Code | LCJ |
| Date Received | 2020-03-10 |
| Model Number | 3549213 |
| Catalog Number | 3549213 |
| Lot Number | 7672049 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-03-10 |