Brand Name | SYMMETRY SHARP KERRISON |
Type of Device | RONGEUR HANDLE |
Manufacturer (Section D) |
SYMMETRY SURGICAL INC |
3034 owen drive |
antioch 37013 |
|
Manufacturer (Section G) |
SYMMETRY SURGICAL INC |
3034 owen drive |
|
antioch TN 37013 |
|
Manufacturer Contact |
victoria
rogers
|
3034 owen drive |
antioch, TN 37013
|
8002513000
|
|
MDR Report Key | 7811497 |
MDR Text Key | 118400960 |
Report Number | 3007208013-2018-00016 |
Device Sequence Number | 1 |
Product Code |
HAE
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K130541 |
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 |
08/23/2018 |
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 Model Number | 53-1674 |
Device Catalogue Number | 53-1674 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
07/23/2018 |
Initial Date FDA Received | 08/23/2018 |
Was Device Evaluated by Manufacturer? |
No
|
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 |
|
|