Brand Name | BLADE, SAW, SAGITTAL, 25 X 90 X 1.19, ST |
Type of Device | BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL |
Manufacturer (Section D) |
CARDINAL HEALTH 247, INC F/K/A EMERGE MEDICAL, INC |
720 s colorado blvd ste 550s |
denver CO 80246 |
|
Manufacturer (Section G) |
CARDINAL HEALTH 247, INC F/K/A EMERGE MEDICAL, INC |
720 s colorado blvd ste 550s |
|
denver CO 80246 |
|
Manufacturer Contact |
michele
donatich
|
1500 waukegan rd |
waukegan, IL 60085
|
|
MDR Report Key | 6038530 |
MDR Text Key | 57917874 |
Report Number | 1423537-2016-00051 |
Device Sequence Number | 1 |
Product Code |
GFA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/18/2016 |
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 |
Physician
|
Device Catalogue Number | C25-119-90 |
Device Lot Number | 160614 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Distributor Facility Aware Date | 09/20/2016 |
Initial Date Manufacturer Received |
09/20/2016
|
Initial Date FDA Received | 10/18/2016 |
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|