Brand Name | EASYPUMP |
Type of Device | PUMP, INFUSION, ELASTOMERI |
Manufacturer (Section D) |
B. BRAUN MELSUNGEN AG |
carl-braun strabe 1 |
melsungen, 34212 |
GM 34212 |
|
Manufacturer (Section G) |
B. BRAUN MELSUNGEN AG |
carl-braun strabe 1 |
|
melsungen, 34212 |
GM
34212
|
|
Manufacturer Contact |
jonathan
severino
|
861 marcon blvd |
allentown, PA 18109
|
4847197287
|
|
MDR Report Key | 19180057 |
MDR Text Key | 341710340 |
Report Number | 9610825-2024-00323 |
Device Sequence Number | 1 |
Product Code |
MEB
|
UDI-Device Identifier | 04046964448638 |
UDI-Public | (01)04046964448638 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K081905 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/25/2024 |
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 | 4540018-02 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/15/2024
|
Initial Date FDA Received | 04/25/2024 |
Was Device Evaluated by Manufacturer? |
No
|
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 |
|
|