Brand Name | ABVISER AUTOVALVE IAP MONITORING DEVICE, PATIENT MOUNT |
Type of Device | DEVICE, CYSTOMETRIC, HYDRAULIC |
Manufacturer (Section D) |
WOLFE TORY MEDICAL INC |
79 west 4500 south suite 18 |
salt lake city UT 84107 |
|
Manufacturer Contact |
jeanette
johnson
|
211 american ave |
greensboro, NC 27409
|
3362973009
|
|
MDR Report Key | 5205307 |
MDR Text Key | 30546261 |
Report Number | 1722554-2015-31258 |
Device Sequence Number | 1 |
Product Code |
FEN
|
Combination Product (y/n) | N |
Reporter Country Code | EZ |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
02/27/2014 |
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? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 05/17/2015 |
Device Model Number | ABV601 |
Device Lot Number | 120529 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/27/2014
|
Initial Date FDA Received | 11/05/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/17/2012 |
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) |
Required Intervention;
|
|
|