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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 5"(13CM) 9-0 BLK SUTURE, NONABSORBABLE, SYNTHETIC

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ETHICON INC. ETHILON SUTURE 5"(13CM) 9-0 BLK SUTURE, NONABSORBABLE, SYNTHETIC Back to Search Results
Model Number 2819G
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Attempts have been made to retrieve the device. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. It was reported:"the needle of the sutures from the lot qbbeqe does not match with the correct one expected for the product code 2819g.

 
Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. It was reported that the needle of the suture from the lot does not match with the correct one expected for the product code. The curve of the needle is different. It was stated the needle looked like a ski type needle. There were no adverse patient consequences reported. The patient was not impacted. Additional information has been requested.

 
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Brand NameETHILON SUTURE 5"(13CM) 9-0 BLK
Type of DeviceSUTURE, NONABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10214481
MDR Text Key197319885
Report Number2210968-2020-04972
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK946173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/26/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number2819G
Device Catalogue Number2819G
Device LOT NumberQBBEQE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/19/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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