Brand Name | ADVANTAGE PLUS |
Type of Device | AUTOMATED ENDOSCOPE REPROCESSOR |
Manufacturer (Section D) |
MEDIVATORS INC. |
14605 28th ave n |
minneapolis MN 55447 |
|
Manufacturer (Section G) |
MEDIVATORS INC. |
14605 28th ave n |
|
minneapolis MN 55447 |
|
Manufacturer Contact |
hannah
shrader
|
14605 28th ave n |
minneapolis, MN 55447
|
7635596863
|
|
MDR Report Key | 8551998 |
MDR Text Key | 143244211 |
Report Number | 2150060-2019-00035 |
Device Sequence Number | 1 |
Product Code |
FEB
|
UDI-Device Identifier | 00677964044755 |
UDI-Public | 00677964044755 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K102996 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
04/25/2019 |
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 |
Other
|
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
03/28/2019 |
Initial Date FDA Received | 04/25/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/28/2011 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|