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Adverse Event Report

ETHICON, INC. PANACRYL (L-LACTIDE/GLYCOLIDE) SUTURE SUTURE, ABSORBABLE   back to search results
Device Problem Reaction
Event Date 01/07/2002
Event Type  Injury   Patient Outcome  Required Intervention;
Manufacturer Narrative

H-6 conclusion: no conclusion can be drawn at this time.

 
Event Description

Report indicates pt developed a suture sinus tract following c-section. Pt was taken to the or for corrective surgical intervention in 2002.

 
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Brand NamePANACRYL (L-LACTIDE/GLYCOLIDE) SUTURE
Type of DeviceSUTURE, ABSORBABLE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ETHICON, INC.
route 22 west
po box 151
somerville NJ 08876 0151
Manufacturer (Section D)
ETHICON, INC.
route 22 west
po box 151
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON, INC. SAN ANGELO
3348 pulliam st
san angelo TX 76905 4403
Manufacturer Contact
mark yale
route 22 west
p.o. box 151
somerville , NJ 08876-0151
(908) 218 -2326
Device Event Key522069
MDR Report Key532795
Event Key505841
Report Number2210968-2004-00346
Device Sequence Number1
Product CodeGAM
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 06/03/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/02/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/07/2002
Device Ageunknown
Event Location Unknown
Date Manufacturer Received06/03/2004
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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? Unknown
Type of Device Usage Initial

Database last updated on January 30, 2009

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