FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

ETHICON, INC. SAN ANGELO COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE   back to search results
Catalog Number J527H
Device Problem Device breakage
Event Date 03/01/1999
Event Type  Malfunction  
Event Description

The surgeon discovered that the needle had broken while he was stitching up tissue. The broken tip was retrieved from the pt.

 
Manufacturer Narrative

Date sent to the fda: 04/21/1999. Visual examination of the actual sample revealed that the needle fractured in a ductile manner due to tensile overload generated during severe mechanical deformation. There were no signs of material or mfg defects.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameCOATED VICRYL (POLYGLACTIN 910) SUTURE
Type of DeviceSUTURE, ABSORBABLE
Baseline Brand NameCOATED VICRYL (POLYGLACTIN 910) SUTURE
Baseline Generic NameABSORBABLE SUTURE
Baseline Catalogue NumberJ527H
Baseline Device FamilyCOATED VICRYL (POLYGLACTIN 910) SUTURE
Baseline Device 510(K) NumberK946271
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed01/01/1980
Manufacturer (Section F)
ETHICON, INC. SAN ANGELO
3348 pulliam st.
san angelo TX 76905 4403
Manufacturer (Section D)
ETHICON, INC. SAN ANGELO
3348 pulliam st.
san angelo TX 76905 4403
Manufacturer (Section G)
ETHICON, INC.
route 22 west
somerville NJ 08876 0151
Manufacturer Contact
georgine pinel
route 22 west
somerville , NJ 08876-0151
(908) 218 -3486
Device Event Key213264
MDR Report Key219903
Event Key206333
Report Number2210968-1999-00229
Device Sequence Number1
Product CodeGAM
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 03/29/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/21/1999
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date01/31/2003
Device Catalogue NumberJ527H
Device LOT NumberLD8084
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/29/1999
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/01/1999
Device Age1 yr
Event Location Hospital
Date Manufacturer Received03/29/1999
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/1998
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

horizonal rule

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