Brand Name | PROLITE MESH |
Type of Device | MESH, SURGICAL, POLYMERIC |
Manufacturer (Section D) |
ATRIUM MEDICAL CORPORATION |
40 continental blvd |
merrimack NH 03054 |
|
MDR Report Key | 10178328 |
MDR Text Key | 195896247 |
Report Number | 3011175548-2020-00840 |
Device Sequence Number | 1 |
Product Code |
FTL
|
Combination Product (y/n) | N |
PMA/PMN Number | K002093 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
06/22/2020 |
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
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
06/08/2020 |
Initial Date FDA Received | 06/22/2020 |
Supplement Dates Manufacturer Received | 07/14/2020
|
Supplement Dates FDA Received | 07/20/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|