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Adverse Event Report

ETHICON ETHICON 2-0 CHROMIC GUT SUTURE   back to search results
Model Number 811H
Event Date 03/16/1997
Patient Outcome  Required Intervention;
Event Description

During episiotomy repair surgeon noted several suture broke and they had to open additional pack. Later that day the pt was taken for a sitz bath at which time a large amount of vaginal bleeding was observed pt was returned to surgery due to the bleeding at which time it was discovered that addl suture had broken. The pt lost a good deal of blood as the result of this incident.

 
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Brand NameETHICON
Type of Device2-0 CHROMIC GUT SUTURE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ETHICON
po box 151
somerville NJ 08876 0151
Manufacturer (Section D)
ETHICON
po box 151
somerville NJ 08876 0151
Device Event Key104650
MDR Report Key106455
Event Key100068
Report Number106455
Device Sequence Number1
Product CodeGAL
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/26/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/02/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number811H
Device LOT NumberHPR154D
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer03/27/1997
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/17/1997
Event Location Hospital
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided

Database last updated on February 28, 2009

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