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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. NUROLON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC

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ETHICON INC. NUROLON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

(b)(4). 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. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Does the surgeon believe that ethicon sutures involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon sutures used in this procedure? are the product code and lot numbers available for all ethicon devices used? citation: clinical neurology and neurosurgery 125 (2014) 137¿142. Http://dx. Doi. Org/10. 1016/j. Clineuro. 2014. 07. 026 - (b)(4).

 
Event Description

It was reported in journal article "octyl-cyanoacrylate skin adhesive is effective for wound closure in posterior spinal surgery without increased risk of wound complications¿ that the patient underwent c3/4 corpectomy with c2-5 interbody hardware, c2-6 pedicle screw and rod construct (psr) and suture was used. The procedure was performed during the period july 2010 through april 2013. For intradural case, the dura was closed with suture in the simple running fashion. Leaks were patched using an autologous muscle patch secured using interrupted suture. The patient experienced infection and was treated with antibiotics. Additional information has been requested.

 
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Brand NameNUROLON NYLON SUTURE UNKNOWN PRODUCT
Type of DeviceSUTURE, NONABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key7207935
MDR Text Key97847849
Report Number2210968-2018-70373
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK946173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 01/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/19/2018
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/03/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/19/2018 Patient Sequence Number: 1
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