MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-09-07 for THERMATRX RX20035C manufactured by American Medical Systems, Inc..
[20791403]
Pt experienced pain during a tmx treatment and the procedure was terminated. It was reported that the catheter temp was reading higher than expected. The catheter was discarded by the site. The pt returned for f/u visit approximately two weeks later and had not experienced any further pain or bleeding. An alternative treatment was administered at that time. Pt was reported to be doing well.
Patient Sequence No: 1, Text Type: D, B5
[20964635]
Dhr was reviewed, no non conformances were noted. Also no other complaints have been received for this lot. 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 | 2183959-2012-02532 |
| MDR Report Key | 2738786 |
| Report Source | 05 |
| Date Received | 2012-09-07 |
| Date of Report | 2012-08-27 |
| Date of Event | 2012-08-08 |
| Date Mfgr Received | 2012-08-08 |
| Date Added to Maude | 2012-09-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RANDY HOYT, SR MGR |
| Manufacturer Street | 10700 BREN RD., WEST |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306277 |
| 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 | 2012-09-07 |
| Catalog Number | RX20035C |
| Operator | LAY USER/PATIENT |
| 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; 2. Deathisabilit | 2012-09-07 |