Brand Name | PERICARDIOCENTESIS KIT |
Type of Device | PERICARDIOCENTESIS KIT |
Manufacturer (Section D) |
MERIT MEDICAL SYSTEMS, INC |
12701 kingston ave |
chester VA 23836 |
|
Manufacturer (Section G) |
MERIT MEDICAL SYSTEMS, INC |
12701 kingston ave |
|
chester VA 23836 |
|
Manufacturer Contact |
jerry
mcphie
|
1600 west merit parkway |
south jordan, UT 84095
|
8012084491
|
|
MDR Report Key | 5780732 |
MDR Text Key | 49128457 |
Report Number | 1125782-2016-00012 |
Device Sequence Number | 1 |
Product Code |
GBX
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
06/16/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/09/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 08/31/2018 |
Device Catalogue Number | PC101 |
Device Lot Number | T901923 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 07/06/2016 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 08/19/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/04/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|