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U.S. Department of Health and Human Services

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

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ETHICON INC. NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Necrosis (1971); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative

(b)(4). This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided. Attempts are being made to obtain the following information. If further details are received at the later date a supplemental medwatch will be sent. Does the surgeon believe that ethicon products 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 product (ethibond or nylon suture) used in this procedure? citation: j reconstr microsurg. 2014; 30: 581 584. Doi: http://dx. Doi. Org/10. 1055/s-0034-1383427. (b)(4).

 
Event Description

It was reported via journal article title : microvascular penile replantation utilizing the deep inferior epigastric vessels author: mark m. Leyngold, md, carlos m. Rivera-serrano, md citation: j reconstr microsurg. 2014; 30: 581 584. Doi: http://dx. Doi. Org/10. 1055/s-0034-1383427. Traumatic penile amputation is an uncommon occurrence described in psychiatric patients with acute psychosis, but can also be a consequence of accidents, circumcision, assault or domestic violence. A (b)(6)male prisoner with a history of gender identity disorder and schizophrenia was rushed to our hospital after a self-inflicted penile amputation with a knife. During the surgical procedure, the proximal and distal arterial to saphenous vein anastomosis were hand sewn with an interrupted nylon 8-o suture with bv130¿5 needle (ethicon) under 3. 5 loop magnification. Penis was well perfused with audible external doppler signals over the glans after completion of all anastomosis. Abdominal fascia was repaired with an ethibond 0 suture (ethicon) leaving a small fascial defect for the vessels. Reported complications included penile replant congestion on post-operative day 1 which required medicinal leech therapy and penile skin necrosis which required debridement and skin grafting. The deep inferior epigastric vessels offer a robust flow and are suitable as recipient vessels in cases of penile replantation when local alternatives are unavailable.

 
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Brand NameNYLON SUTURE UNKNOWN PRODUCT
Type of DeviceSUTURE, NONABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7765215
MDR Text Key116531032
Report Number2210968-2018-75027
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 HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation
Type of Report Initial
Report Date 07/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/08/2018
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 Received07/20/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/08/2018 Patient Sequence Number: 1
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