Brand Name | PANACRYL (L-LACTIDE/GLYCOLIDE) SUTURE |
Type of Device | SUTURE, ABSORBABLE |
Baseline Device 510(K) Number | |
Baseline Device PMA Number | |
Manufacturer (Section F) |
ETHICON, INC. |
route 22 west |
po box 151 |
somerville NJ 08876 0151 |
|
Manufacturer (Section D) |
ETHICON, INC. |
route 22 west |
po box 151 |
somerville NJ 08876 0151 |
|
Manufacturer (Section G) |
ETHICON, INC. SAN ANGELO |
3348 pulliam st |
|
san angelo TX 76905 4403 |
|
Manufacturer Contact |
mark
yale
|
route 22 west |
p.o. box 151 |
somerville
, NJ 08876-0151 |
(908)
218
-2326
|
|
Device Event Key | 522069 |
MDR Report Key | 532795 |
Event Key | 505841 |
Report Number | 2210968-2004-00346 |
Device Sequence Number | 1 |
Product Code | GAM |
Report Source |
Manufacturer
|
Source Type |
Literature,Health Professional
|
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
06/03/2004 |
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 |
Health Professional
|
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 01/07/2002 |
Device Age | unknown |
Event Location |
Unknown
|
Date Manufacturer Received | 06/03/2004 |
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? |
Unknown
|
Type of Device Usage |
Initial
|