Brand Name | PHYSIOMESH |
Type of Device | MESH, SURGICAL, POLYMERIC |
Manufacturer (Section D) |
ETHICON INC. |
1000 route 202 |
raritan NJ 08876 |
|
MDR Report Key | 10442051 |
MDR Text Key | 204003255 |
Report Number | 2210968-2020-06313 |
Device Sequence Number | 1 |
Product Code |
FTL
|
Combination Product (y/n) | N |
PMA/PMN Number | K093932 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,other |
Type of Report
| Initial,Followup |
Report Date |
08/20/2020 |
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 | PHY2025V |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
08/18/2020 |
Initial Date FDA Received | 08/24/2020 |
Supplement Dates Manufacturer Received | 07/01/2021
|
Supplement Dates FDA Received | 07/07/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|