Brand Name | BERLIN HEART EXCOR DRIVING TUBE, BLUE |
Type of Device | VENTRICULAR ASSIST DEVICE |
Manufacturer (Section D) |
BERLIN HEART GMBH |
wiesenweg 10 |
berlin, deu 12247 |
GM 12247 |
|
Manufacturer (Section G) |
BERLIN HEART GMBH |
wiesenweg 10 |
|
berlin, deu 12247 |
GM
12247
|
|
Manufacturer Contact |
dudley
rajapaksa
|
9391 grogan's mill road |
suite a-6 |
the woodlands, TX 77380
|
2818639706
|
|
MDR Report Key | 12781121 |
MDR Text Key | 282121272 |
Report Number | 3004582654-2021-00052 |
Device Sequence Number | 1 |
Product Code |
DSQ
|
UDI-Device Identifier | 04260090040560 |
UDI-Public | 04260090040560 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | P160036 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Replace |
Type of Report
| Initial,Followup |
Report Date |
11/09/2021 |
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 |
Health Professional
|
Device Expiration Date | 05/31/2023 |
Device Model Number | L20H-002X02 |
Device Catalogue Number | L20H-002X02 |
Device Lot Number | 00094146 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/02/2021 |
Initial Date FDA Received | 11/09/2021 |
Supplement Dates Manufacturer Received | 11/02/2021
|
Supplement Dates FDA Received | 02/22/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/18/2020 |
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 |
Patient Age | 52 YR |
Patient Sex | Male |