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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ETHICON 4.0 VICRYL SUTURE

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ETHICON ETHICON 4.0 VICRYL SUTURE Back to Search Results
Model Number 4.0 COATED VICRYL
Event Date 02/23/2016
Event Type  Injury  
Event Description

During laparoscopic abdominal surgery, while closing the sites, the tip of the suture needle broke off. Both pieces were recovered and an add'l package was opened and used.

 
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Brand NameETHICON 4.0 VICRYL SUTURE
Type of DeviceVICRYL SUTURE
Manufacturer (Section D)
ETHICON
somerville NJ 08876
MDR Report Key5476581
Report NumberMW5060690
Device Sequence Number1
Product CodeGAM
Report Source Voluntary
Reporter Occupation Nurse
Report Date 02/29/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/29/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date07/31/2016
Device MODEL Number4.0 COATED VICRYL
Device Catalogue NumberJ496 P34
Device LOT NumberDL2422
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 02/29/2016 Patient Sequence Number: 1
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