Brand Name | PUMP, CONTINUOUS WAVE II |
Type of Device | ARTHROSCOPE |
Manufacturer (Section D) |
ARTHREX, INC. |
1370 creekside boulevard |
naples FL 34108 1945 |
|
Manufacturer (Section G) |
ARTHREX, INC. |
1370 creekside boulevard |
|
naples FL 34108 1945 |
|
Manufacturer Contact |
vik
bajnath, sr. mdr analyst.
|
1370 creekside boulevard |
naples, FL 34108-1945
|
8009337017
|
|
MDR Report Key | 6063762 |
MDR Text Key | 58658207 |
Report Number | 1220246-2016-00429 |
Device Sequence Number | 1 |
Product Code |
HRX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K919721 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial |
Report Date |
10/10/2016 |
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 Catalogue Number | AR-6400 |
Device Lot Number | 4351 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
10/10/2016 |
Initial Date FDA Received | 10/28/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/01/2015 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Treatment | AR-6411, REDEUCE PUMP TUBING, LOT 14690. |
Patient Outcome(s) |
Other;
|
Patient Age | 57 YR |
|
|