Brand Name | GORE FLEX HD MESH IMPLANT |
Type of Device | MESH, SURGICAL, POLYMERIC |
Manufacturer (Section D) |
W.L. GORE & ASSOCIATES,INC. |
|
|
MDR Report Key | 9948018 |
MDR Text Key | 187542711 |
Report Number | MW5094092 |
Device Sequence Number | 1 |
Product Code |
FTL
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Patient
|
Type of Report
| Initial |
Report Date |
04/03/2020 |
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 |
No Information
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 04/09/2020 |
Was Device Evaluated by Manufacturer? |
No Information
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Other;
Disability;
|
Patient Age | 57 YR |
Patient Weight | 51 |
|
|