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

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.

• Brand Name: PROCEED MULTI-LAYER LAMINATE 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.-CORNELIA; 655 ethicon circle; cornelia GA 30531
• Manufacturer Contact: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5914854
• MDR Text Key: 53499362
• Report Number: 2210968-2016-11860
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2016
• Initial Date FDA Received: 08/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/20/2016; 09/20/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention