Brand Name | ELASTOMERIC PUMP |
Type of Device | PUMP, INFUSION, ELASTOMERIC |
Manufacturer (Section D) |
AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) |
|
|
MDR Report Key | 13019007 |
MDR Text Key | 282410149 |
Report Number | MW5106081 |
Device Sequence Number | 1 |
Product Code |
MEB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Pharmacist
|
Type of Report
| Initial |
Report Date |
12/13/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/15/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Model Number | C270020 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|