Brand Name | MGUIDE |
Type of Device | ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS |
Manufacturer (Section D) |
MIS IMPLANTS TECHNOLOGIES LTD. |
p.o. box 7 |
bar lev industrial park |
ha zafon, 20156 00 |
IS 2015600 |
|
Manufacturer (Section G) |
MIS IMPLANTS TECHNOLOGIES LTD. |
p.o. box 7 |
bar lev industrial park |
ha zafon, 20156 00 |
IS
2015600
|
|
Manufacturer Contact |
karl
nittinger
|
221 w. philadelphia st. |
suite 60w |
york, PA 17401
|
7178494424
|
|
MDR Report Key | 8196694 |
MDR Text Key | 131419537 |
Report Number | 3004203816-2018-00001 |
Device Sequence Number | 1 |
Product Code |
NDP
|
Combination Product (y/n) | N |
Reporter Country Code | TU |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,other |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
12/26/2018 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 128054 |
Device Catalogue Number | MG-TMP10 |
Device Lot Number | 128054 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/19/2018 |
Initial Date Manufacturer Received |
12/06/2018 |
Initial Date FDA Received | 12/26/2018 |
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;
|
|
|