MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Pain (1994)

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.No specific patient information regarding events has 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 products used in this procedure? citation: surgical innovation 2014, vol.21(6) 590¿599; please see referenced article attached (b)(4).

Event Description

It was reported via journal article title: is it possible to eliminate sutures in open (lichtenstein technique) and laparoscopic (totally extraperitoneal endoscopic) inguinal hernia repair? a randomized controlled trial with tissue adhesive (n-hexyl-¿-cyanoacrylate) author:alfredo moreno-egea, md citation: surgical innovation 2014, vol.21(6) 590¿599; doi: 10.1177/1553350613517944 the purpose of this randomized, single-blinded study was to evaluate the effectiveness of this new adhesive to treat inguinal hernias, both via open and laparoscopic approaches, as a substitute for sutures.Between jan2008 and jan2011, 208 patients with inguinal hernias of which 102 were unilateral hernias via open surgery using the lichtenstein technique, randomized to receive prolene sutures (n=52; n=37 male and n=15 female; age of 55±14 years) or n-hexyl-cyanoacrylate glue (n=50; n=34 male and n=16 female; age of 57±16 years); and 106 were patients with bilateral inguinal hernias operated upon via totally extraperitoneal laparoscopy and randomized to receive either tackers (n=54; n=39 male and n=15 female; age of 54.9±15.6 years) or glue (n=52; n=36 male and n=16 female; age of 55.8±13.8 years).In the open repair control group, the mesh was fixed with two interruoted 2/0 prolene sutures, the aponeurosis of the external oblique muscle was fixed with 0-prolene sutures and skin with staples.Postoperatively in open repair control group, complications included hematoma (n=5), infection (n=1) and chronic pain >3months (n=3).Although hernioplasty morbidity is low, the formation of local hematomas is the most frequent complication, and this is due to poor hemostasis or vessel traumatism caused by the suture.

• Brand Name: PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• 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 Key: 7627416
• MDR Text Key: 111986260
• Report Number: 2210968-2018-73651
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention