Brand Name | PHYSIOMESH |
Type of Device | MESH, SURGICAL, POLYMERIC |
Manufacturer (Section D) |
ETHICON |
route 22 west |
po box 151 |
somerville NJ 08876 |
|
Manufacturer (Section G) |
ETHICON GMBH & COMPANY KG |
robert - koch - strasse 1 |
po box 1409 |
d-22851 norderstedt NI |
GM
NI
|
|
Manufacturer Contact |
daniel
lamont
|
route 22 west |
po box 151 |
somerville, NJ 08876
|
9082182708
|
|
MDR Report Key | 2127446 |
MDR Text Key | 2019725 |
Report Number | 2210968-2011-00780 |
Device Sequence Number | 1 |
Product Code |
FTL
|
Combination Product (Y/N) | N |
Reporter Country Code | US |
PMA/PMN Number | K093932 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User facility,Company Representative |
Reporter Occupation |
|
Remedial Action |
Other |
Type of Report
| Initial,Followup |
Report Date |
05/25/2011 |
1 Device Was Involved in the Event |
|
1 Patient Was Involved in the Event | |
Date FDA Received | 06/15/2011 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
HEALTH PROFESSIONAL
|
Device EXPIRATION Date | 09/30/2011 |
Device Catalogue Number | PHY0715R |
Device LOT Number | CK9DTHZ0 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Distributor Facility Aware Date | 05/20/2011 |
Device Age | 6 mo |
Event Location |
Other
|
Date Manufacturer Received | 06/16/2011 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Date Device Manufactured | 10/06/2010 |
Is The Device Single Use? |
Yes
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient TREATMENT DATA |
Date Received: 06/15/2011 Patient Sequence Number: 1 |
|
|