Brand Name | POWER SUPPLY |
Type of Device | POWER SUPPLY |
Manufacturer (Section D) |
Q CORE MEDICAL LTD. |
yad haruzim st. 29 |
netanya, 42505 29 |
IS 4250529 |
|
Manufacturer (Section G) |
Q CORE MEDICAL LTD. |
yad haruzim st. 29 |
|
netanya, 42505 29 |
IS
4250529
|
|
Manufacturer Contact |
judith
antler
|
29 yad haruzim st. |
netanya, 42505-29
|
IS
4250529
|
732388861
|
|
MDR Report Key | 5194213 |
MDR Text Key | 30014835 |
Report Number | 3010293992-2015-00193 |
Device Sequence Number | 1 |
Product Code |
MRZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K123049 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/05/2015 |
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 |
No Information
|
Device Catalogue Number | 15072-000-0005 |
Device Lot Number | 5014 & 4914 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Distributor Facility Aware Date | 10/05/2015 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 11/02/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
|
|