Brand Name | IO-TOME |
Type of Device | MANUAL RONGEUR |
Manufacturer (Section D) |
AMENDIA |
1755 west oak parkway |
marietta GA 30062 |
|
Manufacturer (Section G) |
AMENDIA |
1755 west oak parkway |
|
marietta GA 30062 |
|
Manufacturer Contact |
bruce
hooper
|
1755 west oak parkway |
marietta, GA 30062
|
8777553329
|
|
MDR Report Key | 5749741 |
MDR Text Key | 49029671 |
Report Number | 1067095-2016-00012 |
Device Sequence Number | 1 |
Product Code |
HAE
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K113073 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
05/26/2016 |
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 | IO-TOME 10 |
Device Lot Number | 15477 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/26/2016 |
Initial Date FDA Received | 06/25/2016 |
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 |
|
|