Brand Name | ELASOTOMERIC PUMP HOME PUMP |
Type of Device | PUMP, INFUSION, ELASTOMERIC |
Manufacturer (Section D) |
HALYARD/ AVANOS MEDICAL, INC. |
alpharetta GA |
|
MDR Report Key | 10894475 |
MDR Text Key | 218501848 |
Report Number | MW5098050 |
Device Sequence Number | 1 |
Product Code |
MEB
|
Combination Product (y/n) | Y |
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 |
11/11/2020 |
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 Expiration Date | 01/05/2023 |
Device Model Number | C270D50 |
Device Lot Number | 20034838 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 11/23/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Age | 45 YR |
Patient Weight | 128 |
|
|