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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Seroma (2069); Hernia (2240); 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. Attempts are being made to obtain the following information. 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 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: jpma 67: 24; 2017 (b)(4).

 
Event Description

It was reported via journal article "title: hernioplasty: tension free mesh repair versus mayo¿s repair for umbilical hernias" author: nazir ahmed tunio; citation: jpma 67: 24; 2017. This comparative study aimed to compare two different techniques of repairing umbilical hernia. From apr 2009 to dec 2011, 86 patients (n=18 male and n=68 female; age ranged of 25-65 years) with umbilical hernias were randomly allocated group a ¿ tension free mesh repair (n=43) and group b ¿ mayo¿s repair (n=43). In group a, prolene mesh was used to cover the defect and placed over the anterior rectus sheath, anchored by prolene 2/0 in an onlay fashion. In group b, classical steps were applied in which transverse double-breasting repair with non-absorbable suture material prolene no 1 was used. Postoperatively, complications included seroma (n=3 group a; n=1 group b), haematoma (n=1 group a; n=2 group b) and wound infection (n=2 group a; n=4 group b); which were all managed conservatively. On both groups, recurrence (n=1 group a; n=3 group b) was also noted after follow-up of 36 months. On the basis of short hospital stay, early return to normal activity, overall minimum complications and less recurrence rate, the tension free mesh repair was found to be superior than mayo's repair.

 
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Brand NamePROLENE POLYPROPYLENE 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)
ETHICON INC.
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7936191
MDR Text Key122803394
Report Number2210968-2018-76329
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodePK
PMA/PMN NumberK962530
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 09/10/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/04/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2018
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: 10/04/2018 Patient Sequence Number: 1
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