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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE HERNIA SYSTEM UNKNOWN PRODUCT MESH Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Hematoma (1884); Unspecified Infection (1930); Pain (1994); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Citation: hernia (2009) 13:121¿129; doi 10. 1007/s10029-008-0443-4; published online: 13 november 2008 (b)(4).
 
Event Description
It was reported via journal article: "title: prolene hernia system, lichtenstein mesh and plug-and-patch for primary inguinal hernia repair: 3-year outcome of a prospective randomised controlled trial" authors: j. Dalenbäck ¿ c. Andersson ¿ b. Anesten ¿ s. Björck ¿ s. Eklund ¿ o. Magnusson ¿ g. Rimbäck ¿ b. Stenquist ¿ n. Wedel citation: hernia (2009) 13:121¿129; doi 10. 1007/s10029-008-0443-4; published online: 13 november 2008 the aim of this prospective, controlled and randomized study is to to establish if any diverences concerning these aspects could be detected following three principally diverent techniques for primary inguinal hernia repair. The meshes that were used for the respective hernioplasties were for lichtenstein, prolene® mesh 10x15 cm (ethicon inc. , (b)(4)), for p bard perfix® plug size large (davol inc. , (b)(4)) and for phs prolene® hernia system extended (phs, ethicon inc. , (b)(4)). A total of 472 men between 30 and 75 years of age with primary inguinal hernias were included in the study. There were 158 patients in the lichtenstein group, 159 patients in the perfix grou and 155 patients in the phs group respectively. In the lichtenstein group, medial defect inverted by a running absorbable suture (vicryl® 3/0, ethicon inc. , (b)(4)). Mesh and slit part secured and sutured to the shelving margin of poupart¿s ligament just lateral to the completion knot of the running suture, ¿sling¿ mechanism, with a non-absorbable suture (prolene® 2/0). In the p bard perfix group, the plug (bard® perfix® plug, bard/davol inc. , (b)(4)) sutured to the margins of the defect with absorbable sutures (vicryl® 3/0). Direct hernias repaired with xl plug or two l plugs and sutured with 8¿10 interrupted sutures (vicryl® 3/0). Indirect plugs secured with 4¿8 sutures (vicryl® 3/0). If sutures were deemed appropriate, absorbable sutures were used (vicryl® 3/0). Mesh tails brought together with absorbable sutures (vicryl® 3/0). In the phs group, the on-lay graft is sutured with non-absorbable sutures (2/0 prolene) over the pubic tubercle, at the middle of the transversus arch and at the middle of the inguinal ligament. Immediate postoperative complications in the lichtenstein group included minor haematoma (n
=
1) and severe pain (n
=
2) were reported. Late complications, 30 days postoperative days included haematoma (n
=
7), infection (n
=
2) were reported. Immediate postoperative complications in the perfix group included minor haematoma (n
=
2) and severe pain (n
=
1) were reported. Late complications, 30 days postoperative days included haematoma (n
=
17), infection (n
=
1), transient neuralgia (n
=
2) were reported. Immediate postoperative complications in the phs group included minor haematoma (n
=
1) and severe pain (n
=
2) were reported. Late complications, 30 days postoperative days included haematoma (n
=
14), infection (n
=
6), transient neuralgia (n
=
3) were reported. There is no need for any early surgical re-intervention and only one serious event with a deep infection of an l mesh that was removed with subsequent uneventful recovery and no inguinal hernia recurrence during the study period. There are 3 recurrences occurred in the phs group during the 3 years follow-up. In conclusion, all the evaluated mesh techniques are suitable for execution under local anaesthesia. In conclusion, the prolene hernia system and plug-and-patch techniques can be performed with shorter operation times than the lichtenstein method. Early and late outcomes are, however, comparable, with few and insignificant differences concerning complication rates, return to full functional ability and/or pain response.
 
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Brand NamePROLENE HERNIA SYSTEM UNKNOWN PRODUCT
Type of DeviceMESH
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-JPAC
25 centre road
somersworth NH 03878
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7651455
MDR Text Key112843535
Report Number2210968-2018-73941
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K984220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 06/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/29/2018 Patient Sequence Number: 1
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