Brand Name | SUPERTRAX NEEDLE TIP CYTOLOGY BRUSH |
Type of Device | ENDOSCOPIC CYTOLOGY BRUSH |
Manufacturer (Section D) |
SUPERDIMENSION INC. |
161 cheshire lane |
suite 100 |
minneapolis MN 55441 |
|
Manufacturer Contact |
sharon
murphy
|
161 cheshire lane |
suite 100 |
minneapolis, MN 55441
|
2034925267
|
|
MDR Report Key | 5785129 |
MDR Text Key | 49276760 |
Report Number | 3004962788-2016-00179 |
Device Sequence Number | 1 |
Product Code |
FDX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K834402 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/12/2016 |
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 | AKI00140-01 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
06/15/2016 |
Initial Date FDA Received | 07/12/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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) |
Other;
|
Patient Age | 62 YR |