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 2020-03-25 for CE MED HEIGHT TE 800CC 3548226 manufactured by Mentor Texas.
[184999912]
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: deflation. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184999913]
It was reported that a female patient underwent a revision breast reconstruction with a 800cc tissue expander and experienced postoperative right-sided deflation. The expander was had been expanded several times, and it was deflated suddenly. As a result, the patient had the implant explanted on (b)(6) 2020. No saline was left upon explantation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1645337-2020-04803 |
| MDR Report Key | 9881279 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-01-02 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2019-03-01 |
| Date Added to Maude | 2020-03-25 |
| 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 | CE MED HEIGHT TE 800CC |
| Generic Name | EXPANDER, SKIN, INFLATABLE |
| Product Code | LCJ |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-03-13 |
| Catalog Number | 3548226 |
| Lot Number | 7693970 |
| 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. Required No Informationntervention | 2020-03-25 |