MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-31 for MENTOR TISSUE EXPANDER 3549324 manufactured by Mentor Texas.
[185864748]
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: deflation. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185864749]
It was reported that a female patient of an unknown age and ethnicity underwent unspecified breast augmentation with a 550cc mentor tissue expander and experienced unknown side deflation. As a result, the expander was explanted on (b)(6) 2020. Serial number is either (b)(4) if right side effected or (b)(4) if left side is effected. Follow-ups are in progress. Supplemental report will be sent when information is received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1645337-2020-05049 |
| MDR Report Key | 9908319 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-04-01 |
| Device Manufacturer Date | 2019-04-29 |
| Date Added to Maude | 2020-03-31 |
| 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 TISSUE EXPANDER |
| Generic Name | EXPANDER, SKIN, INFLATABLE |
| Product Code | LCJ |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-27 |
| Catalog Number | 3549324 |
| Lot Number | 7720314 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 1. Required No Informationntervention | 2020-03-31 |