Brand Name | STERNAL SAW II BLADE |
Type of Device | BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL-SARNS STERNAL SAW SYSTEMS |
Manufacturer (Section D) |
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
6200 jackson road |
ann arbor MI 48103 |
|
MDR Report Key | 7951340 |
MDR Text Key | 123259214 |
Report Number | 1828100-2018-00532 |
Device Sequence Number | 1 |
Product Code |
GFA
|
Combination Product (y/n) | N |
PMA/PMN Number | K935391 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
12/04/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/10/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Model Number | 5590 |
Device Catalogue Number | 5590 |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 12/03/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|