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

Device Problem 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 - [(b)(4) - shamim 2010 (1).Pdf].

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 second case report was a (b)(6)-year-old male patient who had recurrent left inguinal hernia 3 years after his uncomplicated left inguinal hernia, in which (prolene) mesh hernioplasty.On examination, there was an absence of any prolene mesh over the posterior inguinal wall, though anchoring interrupted prolene sutures were in place.As a treatment, herniotomy was performed with modified lichtenstein¿s repair.The post-operative period was uneventful.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.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, 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 Key: 7607034
• MDR Text Key: 111325607
• Report Number: 2210968-2018-73510
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: PK
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• 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 Received: 06/15/2018
• 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
• Date Manufacturer Received: 05/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR