Brand Name | LEVEL ONE NEURO |
Type of Device | MESH |
Manufacturer (Section D) |
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG |
kolbinger strabe 10 |
muhlheim/donau, 78570 |
GM 78570 |
|
Manufacturer (Section G) |
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG |
kolbinger strabe 10 |
|
muhlheim/donau, 78570 |
GM
78570
|
|
Manufacturer Contact |
jennifer
damato
|
p.o. box 16369 |
jacksonville, FL 32245
|
9046417746
|
|
MDR Report Key | 7397394 |
MDR Text Key | 104382049 |
Report Number | 9610905-2018-00040 |
Device Sequence Number | 1 |
Product Code |
JEY
|
UDI-Device Identifier | 00888118035776 |
UDI-Public | (01)00888118035776 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K944565 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
03/20/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Physician
|
Device Model Number | 25-010-20-09 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Event Location |
Hospital
|
Date Report to Manufacturer | 03/20/2018 |
Initial Date Manufacturer Received |
03/20/2018 |
Initial Date FDA Received | 04/04/2018 |
Supplement Dates Manufacturer Received | 06/29/2018
|
Supplement Dates FDA Received | 07/25/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
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 Outcome(s) |
Other;
|
Patient Age | 66 YR |
|
|