Brand Name | LINA GOLD LOOP, REF. EL-240-8 |
Type of Device | LINA GOLD LOOP, REF. EL-240-8 |
Manufacturer (Section D) |
LINA MEDICAL APS |
formervangen 5 |
glostrup, DK-26 00 |
DA DK-2600 |
|
Manufacturer (Section G) |
LINA MEDICAL POLSKA SP. Z O.O. |
8a rolna, sady |
|
tarnowo podg[?]rne, 62-08 0 |
PL
62-080
|
|
Manufacturer Contact |
joanna
mazur
|
formervangen 5 |
glostrup, DK-26-00
|
DA
DK-2600
|
|
MDR Report Key | 7032628 |
MDR Text Key | 219162638 |
Report Number | 3007699067-2017-00004 |
Device Sequence Number | 1 |
Product Code |
HIN
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K070315 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/27/2017 |
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 | 02/11/2019 |
Device Model Number | EL-240-8 |
Device Catalogue Number | EL-240-8 |
Device Lot Number | 1607037 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
10/05/2017
|
Initial Date FDA Received | 11/15/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|