Brand Name | JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP |
Type of Device | TRAY, SURGICAL, NEEDLE |
Manufacturer (Section D) |
CAREFUSION, INC |
75 north fairway drive |
vernon hills IL 60061 |
|
Manufacturer (Section G) |
CAREFUSION, INC |
zona franca las americas |
|
santo domingo |
DR
|
|
Manufacturer Contact |
anna
wehrheim
|
75 north fairway drive |
vernon hills, IL 60061
|
|
MDR Report Key | 6614542 |
MDR Text Key | 76753787 |
Report Number | 9680904-2017-00109 |
Device Sequence Number | 1 |
Product Code |
FSH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K813338 |
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,Followup |
Report Date |
07/25/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/06/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | DJ4011X |
Device Lot Number | 0001062440 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 05/26/2017 |
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 |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 50 YR |
|
|