Brand Name | STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM |
Type of Device | MESH, SURGICAL |
Manufacturer (Section D) |
LIFECELL |
1 millennium way |
branchburg NJ |
|
Manufacturer (Section G) |
LIFECELL |
1 millennium way |
|
branchburg NJ |
|
Manufacturer Contact |
christopher
belle
|
1 millennium way |
branchburg, NJ
|
9089471470
|
|
MDR Report Key | 11614906 |
MDR Text Key | 243806637 |
Report Number | 1000306051-2021-00024 |
Device Sequence Number | 1 |
Product Code |
FTM
|
UDI-Device Identifier | 00818410010157 |
UDI-Public | 00818410010157 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K070560 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Reporter Occupation |
Other
|
Type of Report
| Initial |
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 | 2025002 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/09/2021 |
Initial Date FDA Received | 04/05/2021 |
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;
|
Patient Age | 57 YR |
|
|