Brand Name | PVP MEDIUM 6.4CM X 6.4CM |
Type of Device | MESH, SURGICAL, POLYMERIC |
Manufacturer (Section D) |
ETHICON INC. |
p.o. box 151, route 22 west |
somerville NJ 08876 |
|
Manufacturer (Section G) |
ETHICON INC.-GMBH |
p.o. box 1409 |
|
norderstedt |
|
Manufacturer Contact |
elba
bello
|
p.o. box 151, route 22 west |
somerville, NJ 08876
|
9082182213
|
|
MDR Report Key | 11536985 |
MDR Text Key | 246065839 |
Report Number | 2210968-2021-02595 |
Device Sequence Number | 1 |
Product Code |
FTL
|
UDI-Device Identifier | 10705031132405 |
UDI-Public | 10705031132405 |
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 |
other |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/18/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/21/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | PVPM |
Device Catalogue Number | PVPM |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 03/17/2021 |
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) |
Required Intervention;
|
|
|