Brand Name | COOLWAVE |
Type of Device | CTT |
Manufacturer (Section D) |
UROLOGIX, LLC |
14406 21st avenue n |
minneapolis, |
|
Manufacturer (Section G) |
UROLOGIX, LLC |
14406 21st avenue n |
|
minneapolis, |
|
Manufacturer Contact |
mark
swanson
|
14406 21st avenue n |
minneapolis, MN 55447
|
7634757648
|
|
MDR Report Key | 8197830 |
MDR Text Key | 131443674 |
Report Number | 2133936-2018-00001 |
Device Sequence Number | 1 |
Product Code |
MEQ
|
UDI-Device Identifier | M876PT10360 |
UDI-Public | M876PT10360 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P970008 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
12/14/2018 |
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 Model Number | PT1036 |
Device Catalogue Number | 410097-001 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 12/26/2018 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Disability;
|
|
|