MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-17 for ARTOURA BREAST TISSUE EXPANDER SMXP130RH manufactured by Mentor Texas.
[184084903]
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 is in progress. Once completed, a supplemental report will be submitted. Reason for device explant and/or reoperation: unknown. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184084904]
On (b)(6) 2020, a 475cc artoura breast tissue expander was received by the mentor failure analysis lab. The devices could not be associated with an existing complaint. In the absence of clarifying information, it cannot be determined why this device was returned to mentor. However, it will be conservatively reported to fda as an event requiring medical device removal per paperwork received with an explant date of (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1645337-2020-04430 |
| MDR Report Key | 9845807 |
| Report Source | OTHER |
| Date Received | 2020-03-17 |
| Date of Report | 2020-02-20 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2019-02-26 |
| Date Added to Maude | 2020-03-17 |
| 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 | ARTOURA BREAST TISSUE EXPANDER |
| Generic Name | EXPANDER, SKIN, INFLATABLE |
| Product Code | LCJ |
| Date Received | 2020-03-17 |
| Returned To Mfg | 2020-02-20 |
| Model Number | SMXP130RH |
| Catalog Number | SMXP130RH |
| Lot Number | 7686732 |
| 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 | 2020-03-17 |