Type of Device | BARRIER, ABSORBABLE, ADHESION |
Manufacturer (Section D) |
ETHICON INC. |
p.o. box 151, route 22 west |
somerville NJ 08876 0151 |
|
Manufacturer (Section G) |
ETHICON INC.-PENDING DETERMINATION |
p.o. box 151, route 22 west |
|
somerville NJ 08876 0151 |
|
Manufacturer Contact |
kenneth
clark
|
route 22 westp o box 151 |
somerville, NJ 08876
|
9082183547
|
|
MDR Report Key | 5995951 |
MDR Text Key | 56333070 |
Report Number | 2210968-2016-14195 |
Device Sequence Number | 1 |
Product Code |
MCN
|
Combination Product (y/n) | N |
PMA/PMN Number | P880047 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup |
Report Date |
02/21/2017 |
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
|
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
09/26/2016
|
Initial Date FDA Received | 10/04/2016 |
Supplement Dates Manufacturer Received | Not provided Not provided
|
Supplement Dates FDA Received | 12/27/2016 03/08/2017
|
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 |
Treatment | TVT-O, INTERCEED, COLOPLAST RESTORELLE |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 34 YR |
|
|