MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-04-23 for THERMATRX RX20025C manufactured by American Medical Systems, Inc..
[3351090]
It was reported that the tmx3000 catheter balloon burst during treatment. There was no reported injury to the pt associated with this event. It was indicated that the treatment was completed.
Patient Sequence No: 1, Text Type: D, B5
[10698939]
Should additional info become available regarding this event it will be re-evaluated and a f/u report will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2013-00803 |
| MDR Report Key | 3084399 |
| Report Source | 05 |
| Date Received | 2013-04-23 |
| Date of Report | 2013-04-03 |
| Date of Event | 2013-04-03 |
| Date Mfgr Received | 2013-04-03 |
| Device Manufacturer Date | 2011-03-01 |
| Date Added to Maude | 2013-06-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON ZURN, DIR |
| Manufacturer Street | 10700 BREN RD., WEST |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306347 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMATRX |
| Generic Name | THERMAL TREATMENT SYSTEM |
| Product Code | MEQ |
| Date Received | 2013-04-23 |
| Catalog Number | RX20025C |
| Device Expiration Date | 2014-01-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 10700 BREN RD., WEST MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-04-23 |