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Adverse Event Report

ETHICON, INC. SAN LORENZO PROLENE POLYPROPYLENE SUTURE SUTURE, NON-ABSORBABLE   back to search results
Catalog Number 8699G
Device Problem Device breakage
Event Date 02/05/2004
Event Type  Injury   Patient Outcome  Other;
Event Description

Customer reported that several suture strands broke one day following skin closure. Pt was re-sutured.

 
Manufacturer Narrative

H-6 conclusion: representative samples of the returned product were tested for knot pull tensile strength and the results obtained were above the ethicon requirements, which always equal or exceed the minimum usp requirements.

 
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Brand NamePROLENE POLYPROPYLENE SUTURE
Type of DeviceSUTURE, NON-ABSORBABLE
Baseline Brand NamePROLENE (POLYPROPYLENE) SUTURE
Baseline Generic NameSUTURE, NON-ABSORBABLE
Baseline Catalogue Number8699G
Baseline Device FamilyPROLENE POLYPROPYLENE SUTURE
Baseline Device 510(K) Number
Baseline Device PMA NumberN16374
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed04/01/1969
Manufacturer (Section F)
ETHICON, INC. SAN LORENZO
road 183, km. 8.3
industrial area
hato PR 00754
Manufacturer (Section D)
ETHICON, INC. SAN LORENZO
road 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
mark yale
route 22 west
p.o. box 151
somerville , NJ 08876-0151
(908) 218 -2326
Device Event Key504661
MDR Report Key515653
Event Key489237
Report Number2210968-2004-00121
Device Sequence Number1
Product CodeGAW
Report Source Manufacturer
Source Type User facility
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 02/13/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/12/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date01/31/2008
Device Catalogue Number8699G
Device LOT NumberSGE397
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/03/2004
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/05/2004
Device Age8 mo
Event Location Unknown
Date Manufacturer Received02/13/2004
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/2003
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?
Type of Device Usage Initial

Database last updated on February 28, 2009

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