MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hematoma (1884); Seroma (2069); Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.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: hernia.2014; 18: 193 198.Doi: 10.1007/s10029-013-1211-7.(b)(4).

Event Description

It was reported via journal article: "title: lichtenstein technique for inguinal hernia repair using polypropylene mesh fixed with sutures vs.Self-fixating polypropylene mesh: a prospective randomized comparative study" authors: g.Chatzimavroudis, b.Papaziogas, i.Koutelidakis, i.Galanis, s.Atmatzidis, p.Christopoulos, t.Doulias, k.Atmatzidis, j.Makris.Citation: hernia.2014; 18: 193 198.Doi: 10.1007/s10029-013-1211-7.The aim of this prospective randomized study was to evaluate the effect of a relatively new mesh with self-fixating properties, used to repair inguinal hernia with the lichtenstein technique, on early and chronic post-operative pain.Between june 2009 and june 2010, a total of 50 patients (48 males and 2 females; mean age of 60.5 ± 17.3 years) with primary unilateral inguinal hernia were treated using the lichtenstein technique.Patients were randomly assigned to receive either a polypropylene mesh, fixed with polypropylene sutures (n- 25; group a), or a self-fixating polypropylene mesh with resorbable polylactic acid microgrips (n-25; group b).During the surgical procedure in group a, the traditional lichtenstein technique was performed using a heavy-weight prolene polypropylene mesh which was trimmed according to each patient¿s inguinal floor size, with special attention to overlap the pubic tubercle by 2 cm medially.The mesh was secured in place with prolene 2-0 sutures.In group b, 1 prolene 2-0 suture was placed superficially to the pubic tubercle to prevent mesh dislocation.In group a, reported complications included seroma (n-7) and hematoma (n-4).In group b, reported complications included seroma (n-10) and hematoma (n-3).In all patients with seroma or hematoma, the fluid collection had been completely absorbed at the 3-month follow-up.It was concluded that the self-fixating mesh can be safely and effectively used for inguinal hernia repair.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7613263
• MDR Text Key: 111460316
• Report Number: 2210968-2018-73551
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K962530
• 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: 05/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2018
• 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