Brand Name | PROCEED VENTRAL PATCH |
Type of Device | MESH, SURGICAL, POLYMERIC |
Manufacturer (Section D) |
JOHNSON & JOHNSON INTERNATIONAL |
leonardo da vincilaan 15 |
diegem 1831 |
BE 1831 |
|
Manufacturer (Section G) |
ETHICON INC.-GMBH |
robert-koch strasse 1 |
|
norderstedt D-228 51 |
GM
D-22851
|
|
Manufacturer Contact |
kenneth
clark
|
route 22 westp o box 151 |
somerville, NJ 08876
|
9082183547
|
|
MDR Report Key | 6026994 |
MDR Text Key | 57343104 |
Report Number | 2210968-2016-60045 |
Device Sequence Number | 1 |
Product Code |
FTL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K061533 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
09/30/2016 |
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
|
Device Catalogue Number | PVPM |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
09/28/2016 |
Initial Date FDA Received | 10/13/2016 |
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
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|