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 | 2070827 |
MDR Text Key | 1853769 |
Report Number | 2210968-2011-00517 |
Device Sequence Number | 1 |
Product Code |
FTL
|
Combination Product (Y/N) | N |
Reporter Country Code | SW |
PMA/PMN Number | K093932 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User facility,Company Representative |
Reporter Occupation |
|
Remedial Action |
Other |
Type of Report
| Initial,Followup |
Report Date |
04/04/2011 |
1 Device Was Involved in the Event |
|
1 Patient Was Involved in the Event | |
Date FDA Received | 04/27/2011 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
HEALTH PROFESSIONAL
|
Device Catalogue Number | PHY1520V |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 05/25/2011 |
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Event Location |
Other
|
Date Manufacturer Received | 05/25/2011 |
Was Device Evaluated By Manufacturer? |
Yes
|
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: 04/27/2011 Patient Sequence Number: 1 |
|
|
|