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Adverse Event Report

ETHICON, INC. SAN ANGELO COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE   back to search results
Catalog Number J946H
Device Problem Suture line separation
Event Date 12/08/2001
Event Type  Injury  
Manufacturer Narrative

Section b5 of facility medwatch 100052-2002-00002 describes two separate incidents with two different pts. Medwatch 2210968-2002-00145 and 2210968-2002-00146 are being submitted for each incident. H6 conclusion: no conclusion can be drawn at this time. Should further info be obtained a supplemental 3500a will be submitted accordingly.

 
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Brand NameCOATED VICRYL (POLYGLACTIN 910) SUTURE
Type of DeviceSUTURE, ABSORBABLE
Baseline Brand NameCOATED VICRYL (POLYGLACTIN 910) SUTURE
Baseline Generic NameABSORBABLE SUTURE
Baseline Catalogue NumberJ946H
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, INC. SAN ANGELO
3348 pulliam street
san angelo TX 76905 4403
Manufacturer Contact
rita mcintyre
route 22 west
po box 151
somerville , NJ 08876-0151
(908) 218 -2398
Device Event Key371090
MDR Report Key382043
Event Key354824
Report Number2210968-2002-00146
Device Sequence Number1
Product CodeGAM
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Invalid Data
Type of Report Initial
Report Date 02/08/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/08/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Invalid Data
Device Catalogue NumberJ946H
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/08/2001
Device Ageunknown
Date Manufacturer Received02/08/2002
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2001
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 February 28, 2009

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