Brand Name | GYNECARE MORCELLEX UNKNOWN PRODUCT |
Type of Device | LAPAROSCOPE, GYNECOLOGIC |
Manufacturer (Section D) |
ETHICON INC. |
p.o. box 151, route 22 west |
somerville NJ 08876 0151 |
|
Manufacturer (Section G) |
MEDTECH GROUP INC |
6 century ln |
|
south plainfield NJ 07080 |
|
Manufacturer Contact |
guillermo
villa
|
route 22 west po box 151 |
somerville, NJ 08876
|
9082180707
|
|
MDR Report Key | 5360521 |
MDR Text Key | 35674462 |
Report Number | 2210968-2016-00639 |
Device Sequence Number | 1 |
Product Code |
HET
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K100280 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,other,use |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/18/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/12/2016 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 12/18/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Death;
Required Intervention;
|