Brand Name | MESH PERFIX PLUG |
Type of Device | SURGICAL MESH |
Baseline Brand Name | MESH COMPOSIX KUGEL |
Baseline Generic Name | SURGICAL MESH |
Baseline Catalogue Number | 00000000 |
Baseline Device Family | MESH-COMPOSITE KUGEL |
Baseline Device 510(K) Number | K003323 |
Baseline Device PMA Number | |
Baseline Shelf Life Information |
Yes
|
Baseline Preamendment? |
Yes
|
Transitional? |
No
|
510(K) Exempt? |
No
|
Shelf Life(Months) | 60 |
Date First Marketed | 02/09/2001 |
Manufacturer (Section F) |
DAVOL, INC., SUB. C.R. BARD, INC. |
100 sockanossett crossroad |
cranston RI 02920 |
|
Manufacturer (Section D) |
DAVOL, INC., SUB. C.R. BARD, INC. |
100 sockanossett crossroad |
cranston RI 02920 |
|
Manufacturer (Section G) |
BARD PUERTO RICO |
las piedras industrial park |
lot #5, p.o. box 2001 |
las piedras PR 00671 |
|
Manufacturer Contact |
thomas
swanson
|
100 sockanossett crossroad |
cranston
, RI 02920 |
(401)
463
-7000
|
|
Device Event Key | 522256 |
MDR Report Key | 532984 |
Event Key | 506028 |
Report Number | 1213643-2004-00057 |
Device Sequence Number | 1 |
Product Code | FTL |
Report Source |
Manufacturer
|
Source Type |
User facility
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
06/17/2004 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 07/02/2004 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
Invalid Data
|
Device Catalogue Number | 00000000 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 06/17/2004 |
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
|
Is the Device an Implant? |
Yes
|
Is this an Explanted Device? |
No Answer Provided
|
Type of Device Usage |
Initial
|
|
|