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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ETHILON NYLON SUTURE SUTURE, NONABSORBABLE, SYNTHETIC

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ETHICON INC. ETHILON NYLON SUTURE SUTURE, NONABSORBABLE, SYNTHETIC Back to Search Results
Catalog Number NW3321
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/28/2019
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. The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

 
Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and suture was used. The doctor opened suture from a box labeled size 3-0, but the actual size of the suture inside the foil was size 4-0. There were no adverse patient consequences reported. No additional information was provided.

 
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Brand NameETHILON NYLON SUTURE
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.-AURANGABAD INDIA
312379@b-15/1
m.i.d.c., 1 walu
aurangabad 43113 3
IN 431133
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
6107428552
MDR Report Key9225255
MDR Text Key165574674
Report Number2210968-2019-88975
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeIN
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
Report Date 09/28/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/23/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberNW3321
Device LOT NumberB9006
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/21/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/21/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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