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

ETHLCON, INC. SAN LORENZO ETHIBOND EXTRA & EXCEL POLYESTER SUTURE SUTURE, NON-ABSORBABLE   back to search results
Catalog Number PXX52
Device Problem Knot
Event Date 09/28/1999
Event Type  Malfunction  
Event Description

Rptr stated that physician noticed the suture knots had come untied on the valve. The surgeon removed the valve and replaced it with a new one using a different suture. There are no reported adverse pt consequences related to this event.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Type of DeviceSUTURE, NON-ABSORBABLE
Baseline Brand NameETHIBOND EXTRA & EXCEL (POLYESTER) SUTURE
Baseline Generic NameSUTURE, NON-ABSORBABLE
Baseline Catalogue NumberPXX52
Baseline Device FamilyEHTIBOND EXTRA & EXCEL POLYESTER SUTURE
Baseline Device 510(K) Number
Baseline Device PMA NumberN17804
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed10/01/1976
Manufacturer (Section F)
ETHLCON, INC. SAN LORENZO
rd 183, km. 8.3
industrial area
hato PR 00754
Manufacturer (Section D)
ETHLCON, INC. SAN LORENZO
rd 183, km. 8.3
industrial area
hato PR 00754
Manufacturer (Section G)
ETHICON, INC. SAN LORENZO
road 183, km. 8.3
industrial area
hato PR 00754
Manufacturer Contact
berkley pollard
route 22 west
po box 151
somerville , NJ 08876-0151
(908) 218 -2005
Device Event Key238482
MDR Report Key246165
Event Key230878
Report Number2210968-1999-00517
Device Sequence Number1
Product CodeGAS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 09/28/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/22/1999
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date07/31/2003
Device Catalogue NumberPXX52
Device LOT NumberLMR328
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/22/1999
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/28/1999
Device Age1 yr
Event Location Hospital
Date Manufacturer Received09/28/1999
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/1998
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/04/1999 Patient Sequence Number: 1
#TreatmentTreatment Date
1,ST. JUDE 521 VALVE, STENTED.,

Database last updated on December 31, 2008

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