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Adverse Event Report

ETHICON, INC. SAN ANGELO SUTURE NEEDLE   back to search results
Device Problem Tip breakage
Event Date 12/10/1998
Event Description

Tip of needle was broken while placing suture.

 
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Type of DeviceSUTURE NEEDLE
Baseline Brand NameCOATED VICRYL (POLYGLACTIN 910) SUTURE
Baseline Generic NameABSORBABLE SUTURE
Baseline Catalogue NumberJ401G
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 street
san angelo TX 76905 4403
Manufacturer (Section D)
ETHICON
somerville NJ 08876 0151
Device Event Key211440
MDR Report Key218009
Event Key204558
Report Number218009
Device Sequence Number1
Product CodeGAM
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 Received04/07/1999
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
OTHER Device ID Number0 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 Date12/15/1998
Event Location Hospital
Date Report TO Manufacturer01/16/1998
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided

Database last updated on January 30, 2009

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