Brand Name | PHYSIOMESH |
Type of Device | MESH, SURGICAL, POLYMERIC |
Manufacturer (Section D) |
ETHICON, INC. |
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 |
GERMANY
NI
|
|
Manufacturer Contact |
daniel
lamont
|
route 22 west |
po box 151 |
somerville
, NJ 08876
|
9082182708
|
|
MDR Report Key | 2704678 |
Report Number | 2210968-2012-04170 |
Device Sequence Number | 1 |
Product Code | FTL |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User facility,Company Representative |
Reporter Occupation |
Physician
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
07/23/2012 |
1 Device Was Involved in the Event |
|
0 PatientS WERE Involved in the Event: | |
Date FDA Received | 08/17/2012 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | PHY1515Q |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Event Location |
Other
|
Date Manufacturer Received | 07/23/2012 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Is The Device Single Use? |
Yes
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
|
|