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 |
mary
szaro
|
route 22 west po box 151 |
somerville, NJ 08876
|
9082183464
|
|
MDR Report Key | 4973528 |
MDR Text Key | 6373531 |
Report Number | 2210968-2015-10871 |
Device Sequence Number | 1 |
Product Code |
MNB
|
Combination Product (y/n) | N |
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 |
Report Date |
06/17/2015 |
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 | 12/10/2016 |
Device Catalogue Number | TC043 |
Device Lot Number | HPMG04 |
Other Device ID Number | 10705031050761 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/14/2015 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
07/20/2015
|
Initial Date FDA Received | 08/05/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/09/2014 |
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 |