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

Catalog Number PHSUNK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Unspecified Infection (1930); Pain (1994); Seroma (2069)

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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: hernia (2004) 8: 64¿66 / doi 10.1007/s10029-003-0180-7.

Event Description

It was reported in a journal article with title: inguinal hernioplasty with the prolene hernia system.The purpose of this retrospective study is to compare early and late complications in patients undergoing inguinal hernia repair with the prolene hernia system (phs) vs the lichtenstein technique, the current criterion standard for inguinal hernioplasties.From mar1998 to oct 2002, a total of 250 patients who underwent inguinal hernia repair were divided into two technique groups: phs group [n=125 (n=81 male, n=44 female, mean age 40.06 years (11-79))] and lichtenstein group [n=125 (n=110 male, n=15 female, mean age 47.98 (13-84))].The phs was formed by an internal round preperitoneal component that reinforces the myopectineal orifice.The external oval component that should be placed over the fascia transversalis to reinforce the floor of the groin.The internal and external components are linked by a cylinder placed in the hernia ring.In both the phs and lichtenstein groups, the mesh was sutured with prolene 2-0.Fifteen days postoperative complication included seroma (n=1), deep wound infection (n=1) and cord edema (n=2); thirty days postoperative complication included disabling chronic pain (n=1).Six months and one year postoperative complications included not disabling chronic pain (n=4).The results of inguinal hernioplasties performed with the phs are comparable to those achieved with lichtenstein hernia repair, the criterion standard technique.

• Brand Name: PROLENE HERNIA SYSTEM 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): J-PAC; 25 centre rd; somersworth NH 03878
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8470480
• MDR Text Key: 140517054
• Report Number: 2210968-2019-79848
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K984220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PHSUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention