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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE* HERNIA SYSTEM MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHSL
Device Problem Failure To Adhere Or Bond (1031)
Patient Problems Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Swelling (2091); No Code Available (3191)
Event Date 04/30/2013
Event Type  Injury  
Manufacturer Narrative

(b)(4) date sent to fda: 10/18/2016. (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. The following information has been requested, but no response has been received. Should any additional information be provided, a supplemental 3500a will be sent: if in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation?.

 
Event Description

It was reported that the patient underwent a left inguinal hernia repair procedure in 2013 and mesh was implanted. The patient reported that they have suffered from severe swelling and pain in the left groin area since the surgery. The patient later underwent exploratory surgery to see what the problem was. It was found that the mesh had come undone on the ends and shrunk into a ball. The mesh was removed and the hernia was repaired. The patient now experiences severe swelling, nerve damage, scar tissue damage and dyspareunia. The pain goes to the left testicle which may have to be removed due to low blood flow to that area of the body. The patient received prescriptions for inflammation and pain. However, the patient no longer takes the anti-inflammatory due to kidney issues. Maude report #: mw5064349.

 
Manufacturer Narrative

Additional information was requested and the following was received: the patient underwent an open left inguinal hernia repair in (b)(6) 2013 and mesh was implanted. The mesh was removed in (b)(6) 2015.

 
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Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
DEFAULT ORGANIZATION
4545 creek rd ml # 36
cincinnati OH 45242 2803
Manufacturer Contact
krystina laguna
route 22 westp o box 151
somerville, NJ 08876
9082183043
MDR Report Key6036301
MDR Text Key57708428
Report Number2210968-2016-14402
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK984220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/30/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/18/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPHSL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/18/2016
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 10/18/2016 Patient Sequence Number: 1
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