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Adverse Event Report

ETHICON INC. PROLENE POLYPROPYLENE SUTURE NON-ABSORBABLE SUTURE   back to search results
Catalog Number M8705
Device Problem Needle, separation
Event Date 05/14/1998
Event Type  Malfunction  
Manufacturer Narrative

Date sent to fda: 11/12/1998. H6 - samples of the returned product were tested for needle pull off and the results obtained were above the usp and ethicon requirements.

 
Event Description

Customer reports that needle prematurely releases from the suture. There are no reported adverse consequences to the pt related to this event.

 
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Brand NamePROLENE POLYPROPYLENE SUTURE
Type of DeviceNON-ABSORBABLE SUTURE
Baseline Brand NamePROLENE* (POLYPROPYLENE) SUTURE
Baseline Generic NameSTERILE SYNTHESIS NONABSORBABLE MONOFILAMENT SUTURE (DYED & UNDYED)
Baseline Catalogue NumberM8705
Baseline Device 510(K) Number
Baseline Device PMA NumberN16374
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed04/01/1969
Manufacturer (Section F)
ETHICON INC.
p.o. box 151
somerville NJ 08876 0151
Manufacturer (Section D)
ETHICON INC.
p.o. box 151
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON, INC.
route 22 west
somerville NJ 08876 0151
Manufacturer Contact
georgine pinel
rte 22 west
somerville , NJ 08876-0151
(908) 218 -3486
Device Event Key167322
MDR Report Key172068
Event Key161698
Report Number2210968-1998-00229
Device Sequence Number1
Product CodeGAW
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/19/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/11/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date01/01/2003
Device Catalogue NumberM8705
Device LOT NumberLAE820
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/18/1998
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/14/1998
Device Age4 mo
Event Location Hospital
Date Manufacturer Received05/19/1998
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/1998
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 January 30, 2009

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