Brand Name | APEX¿ |
Type of Device | COMPOUNDER |
Manufacturer (Section D) |
B. BRAUN MEDICAL INC |
1601 wallace drive, suite 150 |
carrollton TX 75006 6690 |
|
Manufacturer (Section G) |
B. BRAUN MEDICAL INC |
1601 wallace drive, suite 150 |
|
carrollton TX 75006 6690 |
|
Manufacturer Contact |
jonathan
severino
|
861 marcon blvd. |
allentown, PA 18109
|
4847197287
|
|
MDR Report Key | 8296628 |
MDR Text Key | 134720944 |
Report Number | 1641965-2019-00002 |
Device Sequence Number | 1 |
Product Code |
NEP
|
UDI-Device Identifier | 04046964801044 |
UDI-Public | (01)04046964801044 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
03/18/2019 |
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 Model Number | 601220 |
Device Catalogue Number | 601220 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/09/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/22/2019 |
Initial Date FDA Received | 02/01/2019 |
Supplement Dates Manufacturer Received | 01/22/2019
|
Supplement Dates FDA Received | 03/18/2019
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/22/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|