Brand Name | MESH ¿ COMPOSIX L/P |
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 | 15309960 |
MDR Text Key | 298772668 |
Report Number | 1213643-2022-96069 |
Device Sequence Number | 1 |
Product Code |
FTL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K061754 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Consumer |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
08/29/2022 |
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 | UNKAA017 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
08/25/2022 |
Initial Date FDA Received | 08/29/2022 |
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 Sex | Male |
|
|