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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROCEED MULTI-LAYER LAMINATE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROCEED MULTI-LAYER LAMINATE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Itching Sensation (1943); Pain (1994); Scar Tissue (2060); Swelling (2091); Vomiting (2144); Burning Sensation (2146); Ambulation Difficulties (2544); No Code Available (3191)
Event Date 05/14/2010
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.
 
Event Description
It was reported that the patient underwent an abdominal hernia procedure and mesh was implanted. The patient reported that she experienced burning and itching sensations soon after recovery. Years later that patient began experiencing swelling of the hernia surgery region and has begun vomiting occasionally and feeling sick since (b)(6) 2015. The patient had a follow up procedure on (b)(6) 2016 and scar tissue growing above the implantation site of the mesh was found. No additional information has been reported at this time.
 
Manufacturer Narrative
(b)(4). This medwatch report is in response to receipt of maude event report mw5064126. And the following was obtained: it was reported that the patient is experiencing scar tissue build up on the top of belly button where the mesh is rubbing the patient¿s stomach. The patient states that it hurts so badly and daily living activities are affected. The patient is experiencing difficulties to walk or get out of bed. The patient stated that she cannot do anything without feeling of mesh rubbing inside of her, burning, itching and it causing a tremendous amount of pain that she is disabled in bed. The implant is still inside of the patient.
 
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Brand NamePROCEED MULTI-LAYER LAMINATE 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.-CORNELIA
655 ethicon circle
cornelia GA 30531
Manufacturer Contact
kenneth clark
route 22 westp o box 151
somerville, NJ 08876
9082183547
MDR Report Key5914854
MDR Text Key53499362
Report Number2210968-2016-11860
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K060713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received09/01/2016
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 Initial

Patient Treatment Data
Date Received: 08/30/2016 Patient Sequence Number: 1
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