MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-08-11 for AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPY manufactured by American Medical Systems (mn).
[22487493]
Catheter: catalog #: rx20025c, expiration date: 5/21/2017, serial #: (b)(4), manufacture date: 07/2014. Temperature sensor: catalog #: 72404221, expiration date: unknown, serial #: unknown, manufacture date: unknown. The catheter in question was returned for analysis. Functional testing found that the catheter performed within specifications. Visual inspection found nothing notable. The temperature sensor in question did not return for analysis.
Patient Sequence No: 1, Text Type: N, H10
[22487494]
It was reported that the patient started bleeding after the thermatrx catheter was placed but before the heat treatment had begun. It was also indicated that a temperature sensor was giving the high drive voltage error during the same treatment. No additional patient complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2015-00346 |
| MDR Report Key | 4989791 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-08-11 |
| Date of Report | 2015-07-22 |
| Date Mfgr Received | 2015-07-22 |
| Date Added to Maude | 2015-08-11 |
| 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 | MRS. SHARON ZURN |
| Manufacturer Street | 10700 BREN ROAD W |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306000 |
| Manufacturer G1 | AMERICAN MEDICAL SYSTEMS (MN) |
| Manufacturer Street | 10700 BREN ROAD W |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPY |
| Generic Name | SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BPH), THERMOTHERAPY |
| Product Code | MEQ |
| Date Received | 2015-08-11 |
| Returned To Mfg | 2015-08-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS (MN) |
| Manufacturer Address | 10700 BREN ROAD W MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-11 |