Type of Device | ANTI-CD30 (BER-H2) MOUSE MONOCLONAL PRIMARY ANTIBODY |
Manufacturer (Section D) |
VENTANA MEDICAL SYSTEMS, INC |
1910 e innovation park drive |
tucson AZ 85755 1962 |
|
Manufacturer (Section G) |
VENTANA MEDICAL SYSTEMS INC |
1910 e innovation park dr |
none |
tucson AZ 85755 |
|
Manufacturer Contact |
tim
giblin
|
1910 east innovation park dr |
na |
tuscon, AZ 85755
|
5208777035
|
|
MDR Report Key | 6114572 |
MDR Text Key | 60425124 |
Report Number | 2028492-2016-00005 |
Device Sequence Number | 1 |
Product Code |
NJT
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
11/18/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 790-4858 |
Device Catalogue Number | 07007841001 |
Device Lot Number | F09491 |
Other Device ID Number | UDI #04015630972722 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/25/2016
|
Initial Date FDA Received | 11/18/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|