Brand Name | ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL |
Type of Device | MESH, SURGICAL, POLYMERIC |
Manufacturer (Section D) |
ETHICON INC. |
p.o. box 151, route 22 west |
somerville NJ 08876 0151 |
|
Manufacturer (Section G) |
ETHICON INC. |
p.o. box 151, route 22 west |
|
somerville 08876 0151 |
|
Manufacturer Contact |
darlene
kyle
|
p.o. box 151, route 22 west |
somerville, NJ 08876-0151
|
9082182792
|
|
MDR Report Key | 7280024 |
MDR Text Key | 100404796 |
Report Number | 2210968-2018-70898 |
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 |
other |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
06/04/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/19/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 04/30/2014 |
Device Catalogue Number | PHY1520V |
Device Lot Number | EE8DMMA0 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 06/04/2018 |
Date Device Manufactured | 05/01/2012 |
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;
|
Patient Age | 47 YR |
Patient Weight | 144 |
|
|