Brand Name | GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY |
Type of Device | DEVICE, THERMAL ABLATION, ENDOMETRIAL |
Manufacturer (Section D) |
ETHICON INC. |
p.o. box 151, route 22 west |
somerville NJ 08876 015 |
|
Manufacturer (Section G) |
ETHICON INC.-JUAREZ |
avenida de las torres 7125, co |
l salvacar |
ciudad juarez 3260 4 |
MX
32604
|
|
Manufacturer Contact |
guillermo
villa
|
route 22 west po box 151 |
somerville, NJ 08876
|
9082180707
|
|
MDR Report Key | 4768506 |
MDR Text Key | 5949138 |
Report Number | 2210968-2015-05613 |
Device Sequence Number | 1 |
Product Code |
MNB
|
Combination Product (y/n) | N |
Reporter Country Code | SF |
PMA/PMN Number | P970021 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
04/20/2015 |
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 |
Health Professional
|
Device Expiration Date | 09/19/2016 |
Device Catalogue Number | TC033 |
Device Lot Number | HKMG08 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/13/2015 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
05/21/2015 |
Initial Date FDA Received | 05/13/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 06/15/2015
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/18/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|