MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-11-10 for AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPY 72404311R manufactured by American Medical Systems (mn).
[5050848]
It was reported that the console temperature went beyond the prescribed temperature and caused discomfort to the patient. It was also indicated that some patients needed a catheter to be inserted after treatment due to urinary retention. No additional patient complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
[12442473]
The console in question was returned for evaluation. Analysis results indicate the console performed within specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2014-00502 |
| MDR Report Key | 4241433 |
| Report Source | 05 |
| Date Received | 2014-11-10 |
| Date of Report | 2014-10-14 |
| Date of Event | 2014-09-09 |
| Date Mfgr Received | 2014-10-14 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2014-11-10 |
| 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 | 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 | 2014-11-10 |
| Returned To Mfg | 2014-10-28 |
| Catalog Number | 72404311R |
| 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. Required No Informationntervention | 2014-11-10 |