MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-02-22 for THERMATRX RX20045C manufactured by American Medical Systems, Inc..
[2521632]
Info was received indicating that the 4. 5cm catheter used for the thermatrx treatment on (b)(6) 2012 seemed wider than usual. The info indicated that the catheter was wider at the coil area and the insertion into the pt was more difficult. On completion of the procedure the pt's meatus appeared stretched. On (b)(6) /2012 at a follow up visit, urethral strictures were found and treated with dilatation. Report indicates the pt is doing well.
Patient Sequence No: 1, Text Type: D, B5
[9656505]
Should add'l info become available regarding this revision surgery it will be re-evaluated and a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183959-2012-00148 |
| MDR Report Key | 2473800 |
| Report Source | 05,07 |
| Date Received | 2012-02-22 |
| Date of Report | 2012-01-26 |
| Date of Event | 2012-01-26 |
| Date Mfgr Received | 2012-01-26 |
| Date Added to Maude | 2012-03-02 |
| 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 | JON CORNELL, SR MGR |
| Manufacturer Street | 10700 BREN RD., WEST |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306670 |
| 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 | 2012-02-22 |
| Catalog Number | RX20045C |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2012-02-22 |