Brand Name | AVANOS HOMEPUMP C-SERIES ELASTOMERIC PUMP |
Type of Device | PUMP, INFUSION, ELASTOMERIC |
Manufacturer (Section D) |
AVANOS MEDICAL, INC. |
5405 windward parkway |
alpharetta GA 30004 |
|
MDR Report Key | 12597712 |
MDR Text Key | 275402926 |
Report Number | 12597712 |
Device Sequence Number | 1 |
Product Code |
MEB
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
10/06/2021 |
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 |
No Information
|
Device Model Number | 5FU C SERIES |
Device Lot Number | 30117472 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 10/06/2021 |
Event Location |
Outpatient Treatment Facility
|
Date Report to Manufacturer | 10/08/2021 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 10/08/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|