Brand Name | AMS THERMATRX TMX-3000 OFFICE THERMOTHERAPY |
Type of Device | SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BPH), THERMOTHERAPY |
Manufacturer (Section D) |
AMERICAN MEDICAL SYSTEMS (MN) |
10700 bren road w |
minnetonka MN 55343 |
|
Manufacturer (Section G) |
AMERICAN MEDICAL SYSTEMS (MN) |
10700 bren road w |
|
minnetonka MN 55343 |
|
Manufacturer Contact |
sharon
zurn
|
10700 bren road w |
minnetonka, MN 55343
|
9529306000
|
|
MDR Report Key | 4241433 |
MDR Text Key | 5050848 |
Report Number | 2183959-2014-00502 |
Device Sequence Number | 1 |
Product Code |
MEQ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P000043 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
10/14/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 72404311R |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/28/2014 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/14/2014
|
Initial Date FDA Received | 11/10/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/01/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|