MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-26 for CPX4 WITH SUTURE TABS MEDIUM HEIGHT SMOOTH EXPANDER 3509214 manufactured by Mentor Texas.
[185214148]
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. A manufacturing record evaluation is in progress. Once completed, a supplemental report will be submitted. Reason for device explant and/or reoperation: na. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185214149]
It was reported that a 550cc mentor cpx4 with suture tabs medium height smooth expander was used during a breast surgery and exhibited issues with the addition of expansion fluid intra-operatively. During the implantation surgery, the surgeon was not able to remove air or inject saline. As a result, it caused a 5-10 minutes procedural delay , and a replacement device was used to complete the surgery. The physician did not assess any additional risk to the patient as a result of the delay, and no patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1645337-2020-04874 |
| MDR Report Key | 9886181 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-09-16 |
| Date Added to Maude | 2020-03-26 |
| 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 | CPX4 WITH SUTURE TABS MEDIUM HEIGHT SMOOTH EXPANDER |
| Generic Name | EXPANDER, SKIN, INFLATABLE |
| Product Code | LCJ |
| Date Received | 2020-03-26 |
| Catalog Number | 3509214 |
| Lot Number | 9366038 |
| 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 | 2020-03-26 |