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 MENTOR CPX 4 BREAST TISSUE EXPANDER 3548214 manufactured by Mentor Texas.
[183647180]
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. A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint. In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures. Reason for device explant and/or reoperation: breast cancer. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183647181]
It was reported that a female patient underwent a revision breast reconstruction with a 550cc mentor cpx 4 breast tissue expander and experienced postoperative right-sided breast cancer. As a result, the patient? S expander was replaced with a 500cc mentor smooth round moderate plus profile prosthesis (catalog #: 3502500, lot #: 9371038) on (b)(6) 2019. Multiple attempts were made to obtain additional details regarding this event. However, no further information has been received at this time. A supplemental report will be submitted if additional information becomes available in the future.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1645337-2020-04208 |
| MDR Report Key | 9833022 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-14 |
| Date of Report | 2020-02-13 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2019-05-07 |
| 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 | MENTOR CPX 4 BREAST TISSUE EXPANDER |
| Generic Name | EXPANDER, SKIN, INFLATABLE |
| Product Code | LCJ |
| Date Received | 2020-03-14 |
| Returned To Mfg | 2020-03-06 |
| Model Number | 3548214 |
| Catalog Number | 3548214 |
| Lot Number | 7724532 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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. Life Threatening; 2. Required No Informationntervention | 2020-03-14 |