Type of Device | ADHESIVE, TOPICAL SKIN |
Manufacturer (Section D) |
ETHICON INC. |
p.o. box 151, route 22 west |
somerville NJ 08876 015 |
|
Manufacturer (Section G) |
ETHICON INC.-SAN LORENZO PR |
982 road 183 km 8.3 |
|
san lorenzo PR 0075 4 |
|
Manufacturer Contact |
guillermo
villa
|
route 22 west po box 151 |
somerville, NJ 08876
|
9082180707
|
|
MDR Report Key | 3824882 |
MDR Text Key | 4503271 |
Report Number | 2210968-2014-06450 |
Device Sequence Number | 1 |
Product Code |
MPN
|
Combination Product (y/n) | N |
Reporter Country Code | KN |
PMA/PMN Number | K100423 |
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 |
05/08/2014 |
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 Catalogue Number | APPXL6 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
06/06/2014 |
Initial Date FDA Received | 05/21/2014 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 06/18/2014
|
Was Device Evaluated by Manufacturer? |
No
|
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 |
Patient Outcome(s) |
Required Intervention;
|
|
|