Brand Name | VENTRALIGHT ST MESH |
Type of Device | SURGICAL MESH |
Manufacturer (Section D) |
DAVOL INC., SUB. C.R. BARD, INC. |
100 crossings blvd. |
warwick RI 02886 |
|
Manufacturer (Section G) |
BARD SHANNON LIMITED 3005636544 |
san geronimo industrial park |
lot #1, road #3, km 79.7 |
humacao PR 00791 |
|
Manufacturer Contact |
andrew
topoulos
|
100 crossings blvd. |
warwick, RI 02886
|
4018258495
|
|
MDR Report Key | 10075479 |
MDR Text Key | 193038765 |
Report Number | 1213643-2020-04942 |
Device Sequence Number | 1 |
Product Code |
FTL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K101851 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
06/10/2020 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 05/20/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Expiration Date | 04/28/2020 |
Device Catalogue Number | 5954450 |
Device Lot Number | HUCP2569 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/18/2020 |
Is the Reporter a Health Professional? |
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 06/01/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/09/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
|
|