MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-01-08 for THERMATRX THERMO THERAPY manufactured by American Medical Systems, Inc..
[3149491]
The pt reported that he had a thermatrx procedure performed in (b)(6). Pt's report stated "the result was i could not urinate on my own at all. Had a catheter for 4 weeks until a turp could be scheduled. Still have necrotic tissue in prostate causing problems and may need a second turp. " pt indicated he was disappointed with the thermatrx procedure.
Patient Sequence No: 1, Text Type: D, B5
[10427526]
Should additional info become available regarding this revision surgery, it will be re-evaluated and a f/u report will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2013-00100 |
| MDR Report Key | 2909786 |
| Report Source | 04 |
| Date Received | 2013-01-08 |
| Date of Report | 2013-01-01 |
| Date of Event | 2012-08-01 |
| Date Mfgr Received | 2013-01-01 |
| Date Added to Maude | 2013-01-14 |
| 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 THERMO THERAPY |
| Generic Name | THERMOTHERAPY TREATMENT SYSTEM |
| Product Code | MEQ |
| Date Received | 2013-01-08 |
| 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. Required No Informationntervention; 2. Deathisabilit | 2013-01-08 |