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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE HERNIA SYSTEM MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHSMUNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Fever (1858); Hematoma (1884); Pain (1994); Seroma (2069); Urinary Tract Infection (2120); Post Operative Wound Infection (2446)
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. Attempts are being made to obtain the additional information. To date no response has been provided. If further details are received at the later date a supplemental medwatch will be sent. Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Does the surgeon believe that ethicon product (prolene hernia system) 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 product involved? citation: j of evolution of med and dent sci/ eissn- 2278-4802, pissn- 2278-4748/ vol. 4/ issue 36/ may 04, 2015; doi: 10. 14260/jemds/2015/907. Please see article. (b)(4).

 
Event Description

Title : study of prolene hernia mesh system in management of primary inguinal hernia repair. The objective is to study feasibility of using the prolene hernia system, postoperative results in terms of patients comfort, hospital stay, and duration to return to normal activity, postoperative complications and recurrence rates. From jun2005 to jun2007, 75 patients (n=72 male and n=3 female; n=16 ages 30-40 years, n=20 41-50 years, n=19 51-60 years, n=15 61-70 years, and n=5 71-80 years) with inguinal hernia underwent primary inguinal repair. In the procedure, the onlay mesh (prolene hernia system) was spread out over the posterior wall of the inguinal canal and was fixed using 3-4 interrupted sutures of 2-0 polypropylene. Postoperative complications included cord oedema (n=3) which subsided within 10-15 days with conservative management, seroma formation (n=2) , haematoma (n=1) which subsided within 7-10 days, fever secondary to urinary tract infection (n=2) managed conservatively with antibiotics, wound infection (n=1) took 1 month to resolve following treatment with broad spectrum antibiotics, chronic groin pain (n=2) which took 2 months to subside, and persistent cord oedema (n=1) which took 3 weeks to resolved following anti-inflammatory treatment. The prolene hernia system provides all the advantages of a tension-free repair, including less discomfort, rapid return to normal activity low recurrence rates and minimum postoperative complications.

 
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Brand NamePROLENE HERNIA SYSTEM MESH 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 Key8476230
MDR Text Key140742513
Report Number2210968-2019-79928
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberK984220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
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 Received04/02/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPHSMUNK
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? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/02/2019 Patient Sequence Number: 1
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