Brand Name | PRESSURE INFUSION BAG |
Type of Device | INFUSOR, PRESSURE, FOR I.V. BAGS |
Manufacturer (Section D) |
MERIT MEDICAL SYSTEMS, INC. |
south jordan UT |
|
Manufacturer Contact |
jerry
mcphie
|
1600 west merit pkwy. |
south jordan, UT 84095
|
8012084491
|
|
MDR Report Key | 4137582 |
MDR Text Key | 4946341 |
Report Number | 1721504-2014-00236 |
Device Sequence Number | 1 |
Product Code |
KZD
|
Combination Product (y/n) | N |
Reporter Country Code | FI |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
09/03/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | PIB500 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/03/2014
|
Initial Date FDA Received | 09/26/2014 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|