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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 Problems Component Missing (2306); Device Operates Differently Than Expected (2913)
Patient Problem Hernia (2240)
Event Type  Injury  
Manufacturer Narrative
(b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Was there evidence that led surgeon to believe the ethicon product was counterfeit? citation: hernia (2010) 14:313¿315; doi 10. 1007/s10029-009-0536-8.
 
Event Description
It was reported via journal article: "title: recurrent inguinal hernia due to mesh dissolution: two case reports". Author: m. Shamim. Citation: hernia (2010) 14:313¿315; doi 10. 1007/s10029-009-0536-8. The author presented two cases of inguinal hernia recurrences after mesh hernioplasty. The first report was a 38-year-old male patient who had recurrence of right inguinal hernia 6 months after an uncomplicated complete right inguinal hernia, in which (prolene) mesh hernioplasty was done. On re-exploration, the anchoring interrupted prolene sutures were in place, but there was an absence of mesh. As a treatment, herniotomy was performed with darning¿s and lichtenstein¿s repair in a single step. There was no recurrence at 3 years. In this report, the cause of recurrence was the absorption or dissolution of non-absorbable polypropylene (prolene) mesh. A counterfeit version of ethicon¿s prolene (polypropylene) mesh has been known to be distributed to usa hospitals and used in patients undergoing tension-free hernia repair. The implantation of counterfeit/pirated prolene polypropylene mesh can lead to adverse events such as recurrences (from complete dissolution/absorption). The surgeons dealing with hernias should know the difference between original and pirated prolene mesh. Additional reinforcement of the posterior wall of the inguinal canal can be done in cases of doubt in order to avoid recurrence.
 
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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.
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7607089
MDR Text Key111304407
Report Number2210968-2018-73509
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodePK
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 05/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2018
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/15/2018 Patient Sequence Number: 1
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