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Adverse Event Report

ETHICON, INC. SAN ANGELO MONOCRYL (POLLGLECAPRONE 25) SUTURE SUTURE, ABSORBABLE   back to search results
Catalog Number Y426H
Device Problem Reaction
Event Date 03/15/2001
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

It was reported that 2 weeks after a bunion removal procedure the subcuticular sutures were spitting and irritating the skin. The sutures were surgically removed. Patient is doing well.

 
Manufacturer Narrative

H-6: conclusion: suture spitting and suture granuloma are regarded as manifestations of a foreign body reaction and are physiological responses which are exhibited in certain individuals and in the presence of suture material. The product insert which accompanies each device package states that a minimal acute inflammatory response may occur. This reaction normally subsides when the suture has completely absorbed.

 
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Brand NameMONOCRYL (POLLGLECAPRONE 25) SUTURE
Type of DeviceSUTURE, ABSORBABLE
Baseline Brand NameMONOCRYL (POLIGLECAPRONE 25) SUTURE
Baseline Generic NameABSORBABLE SUTURE
Baseline Catalogue NumberY426H
Baseline Device FamilyMONOCRYL (POLIGLECAPRONE 25) SUTURE
Baseline Device 510(K) NumberK920978
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Date First Marketed07/01/1992
Manufacturer (Section F)
ETHICON, INC. SAN ANGELO
3348 pulliam street
san angelo TX 76905 4403
Manufacturer (Section D)
ETHICON, INC. SAN ANGELO
3348 pulliam street
san angelo TX 76905 4403
Manufacturer Contact
berkley pollard
route 22 west
p.o. box 151
somerville , NJ 08876-0151
(908) 218 -2005
Device Event Key323843
MDR Report Key334498
Event Key314827
Report Number2210968-2001-00233
Device Sequence Number1
Product CodeGAN
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Physician
Type of Report Initial
Report Date 04/25/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/24/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberY426H
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/15/2001
Device Ageunknown
Event Location Hospital
Date Manufacturer Received04/25/2001
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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

Database last updated on December 31, 2008

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