Type of Device | DRILLS, BURRS, TREPHINES & ACC. |
Manufacturer Contact |
james
kenney
|
325 paramount drive |
raynham, MA 02767
|
5088282726
|
|
MDR Report Key | 3770698 |
MDR Text Key | 4360160 |
Report Number | 1226348-2014-11427 |
Device Sequence Number | 1 |
Product Code |
HBF
|
Combination Product (y/n) | N |
Reporter Country Code | IN |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/24/2014 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Other
|
Device Catalogue Number | 26-1221 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/31/2012 |
Date Manufacturer Received | 04/23/2014 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|