Brand Name | PHYSIOMESH |
Type of Device | MESH, SURGICAL |
Manufacturer (Section D) |
ETHICON INC. |
p.o. box 151, route 22 west |
somerville NJ 08876 0151 |
|
Manufacturer (Section G) |
ETHICON INC.-GMBH |
robert-koch strasse 1 |
|
norderstedt D-228 51 |
GM
D-22851
|
|
Manufacturer Contact |
ken
clark
|
route 22 west po box 151west p |
o box 151 |
somerville, NJ 08876
|
9082183547
|
|
MDR Report Key | 5612626 |
MDR Text Key | 43838207 |
Report Number | 2210968-2016-08571 |
Device Sequence Number | 1 |
Product Code |
FTL
|
Combination Product (y/n) | N |
PMA/PMN Number | K093932 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
04/11/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/27/2016 |
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? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 04/07/2016 |
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) |
Other;
|
|
|