|
Device Problem
Tip breakage
|
Event Date 12/10/1998 |
|
Event Description
|
Tip of needle was broken while placing suture.
|
|
Search Alerts/Recalls
|
|
|
Type of Device | SUTURE NEEDLE |
Baseline Brand Name | COATED VICRYL (POLYGLACTIN 910) SUTURE |
Baseline Generic Name | ABSORBABLE SUTURE |
Baseline Catalogue Number | J401G |
Baseline Device Family | COATED VICRYL (POLYGLACTIN 910) SUTURE |
Baseline Device 510(K) Number | K946271 |
Baseline Device PMA Number | |
Baseline Shelf Life Information |
Yes
|
Baseline Preamendment? |
No
|
Transitional? |
No
|
510(K) Exempt? |
No
|
Shelf Life(Months) | 60 |
Date First Marketed | 01/01/1980 |
Manufacturer (Section F) |
ETHICON, INC. SAN ANGELO |
3348 pulliam street |
san angelo TX 76905 4403 |
|
Manufacturer (Section D) |
ETHICON |
somerville NJ 08876 0151 |
|
Device Event Key | 211440 |
MDR Report Key | 218009 |
Event Key | 204558 |
Report Number | 218009 |
Device Sequence Number | 1 |
Product Code | GAM |
Report Source |
User Facility
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
12/15/1998 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 04/07/1999 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
OTHER Device ID Number | 0 MO-4 J401D |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 12/15/1998 |
Event Location |
Hospital
|
Date Report TO Manufacturer | 01/16/1998 |
Is the Device an Implant? |
Yes
|
Is this an Explanted Device? |
No Answer Provided
|
|
|
Database last updated on January 30, 2009
![horizonal rule](http://www.fda.gov/graphics/blkpixel.gif)
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH