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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE HERNIA SYSTEM UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
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.
 
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Brand NamePROLENE HERNIA SYSTEM UNKNOWN PRODUCT
Type of DeviceMESH, 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 Key8470480
MDR Text Key140517054
Report Number2210968-2019-79848
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K984220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received04/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPHSUNK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/01/2019 Patient Sequence Number: 1
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