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); Seroma (2069)

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.Citation: ann surg 2015;262:714¿720; doi: 10.1097/sla.0000000000001458.(b)(4).

Event Description

It was reported via journal article: "title: randomized multicenter trial comparing glue fixation, self-gripping mesh, and suture fixation of mesh in lichtenstein hernia repair (finnmesh study)" authors: kirsi ronka, md, jaana vironen, md, phd, jyrki kossi, md, phd, tanja hulmi, md, seppo silvasti, md, tapio hakala, md, phd, imre ilves, md, indrek song, md, merja hertsi, md, petri juvonen, md, phd, and hannu paajanen, md, phd.Citation: ann surg 2015;262:714¿720; doi: 10.1097/sla.0000000000001458.This randomized, parallel, prospective, multicenter study aimed to compare the early postoperative outcomes (pain scores, operative time, wound complications) and 1-year results of lichtenstein hernioplasty using 3 different meshes and 3 fixation techniques in day-case surgery setting.Between jan2012 and dec2013, 625 patients with inguinal hernia underwent lichtenstein hernioplasty and were allocated to three groups based on the fixation materials used: optilene glue fixation (n=216; n=198 male and n=18 female; mean age of 59 [14] years), progrip self-fixation (n=202; n=192 male and n=10 female; mean age of 56 [14] years) and ultrapro suture fixation (n=207; n=195 male and n=12 female; mean age of 57 [14] years).In suture fixation group, the mesh used was ultrapro and was fixed using 2-0 prolene sutures.Postoperatively in suture fixation group, 14 patients developed wound hematoma and 8 patients had seroma or infection which were treated by revision/antibiotics.In a 1-year follow-up in suture fixation group, mild bulging of the operating area and visual analog scale =3 (considered as chronic pain) were observed in 1 and 12 patients, respectively.The pain was managed with analgesics.Recurrences observed on a one-year follow-up were rare and were not dependent on the fixation method of the mesh.Several surgeon-dependent factors contribute to the good clinical results of our trial: experienced surgeons, identification and dissection of the nerves whenever possible, a meticulous surgical technique that resulted in few wound hematomas, and only few patients staying in the hospital for more than 24 hours.

• 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: 7622865
• MDR Text Key: 111836258
• Report Number: 2210968-2018-73607
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2018

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: 05/30/2018
• Initial Date FDA Received: 06/20/2018
• 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