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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE MYCROMESH® BIOMATERIAL MESH, SURGICAL, POLYMERIC

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W.L. GORE & ASSOCIATES GORE MYCROMESH® BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Hole In Material (1293)
Patient Problems Pain (1994); Scar Tissue (2060); Swelling (2091)
Event Date 10/04/2012
Event Type  Injury  
Manufacturer Narrative
A review of the manufacturing records could not be conducted because the lot number is unavailable. The device remains implanted, therefore a direct product analysis was not possible. It was reported that after the original implant on (b)(6) 2012, the pre-existing pain and swelling was persistent and never went away. No antibiotics were administered and a needle aspiration was not performed. Additionally, it was alleged that there is a hole in the mesh and the mesh needed to be removed. The patient had a reoperation on (b)(6) 2016 to repair the recurrent hernia, however it was reported that the mesh was not removed and the hole was not repaired. The item/part number of the implanted device is unknown, however the reference to "mesh tails" and also the reference to "nerves being away from the mesh" suggests the product is most likely a key-holed mycromesh. The implanting physician is a very long standing user of mycromesh.
 
Event Description
Gore received notification from the fda of a voluntary medwatch (mw5063793) which reported the following: i had a severe hernia where my intestines were coming through. I was in intense pain, nausea, and swelling in my left groin and thigh. Dr (b)(6) of the (b)(6) performed surgery when he used gore-tex mesh to repair the hernia. He told me i would have no more pain. I have had continuous pain and one year later i told him i was still in pain. He told me it was scar tissue and i would be fine. The pain continued and has gotten even worse with swelling and there is now a lump there. So i went to a specialist last week who told me that the hernia came back through and i will have to have another surgery to correct the issue without the gore-tex. He explained that this technique does not work and causes issues. I have suffered for 3 years due to the gore-tex mesh. My doctor says he has to remove the mesh. Additional information obtained alleges a hole in the mesh which is causing the problem and requires removal of the device.
 
Manufacturer Narrative
Initial information alleged a hole in the mesh material as reported by the patient's spouse. This information was claimed to have been received by the spouse from the patient's physician. During the investigation, subsequent information received from the physician's staff stated that "he [the physician] never saw the mesh. " with this statement provided by the physician's staff, there is no information to suggest that a hole in the mesh developed post implant. As there is no reported hole in the mesh material, this medwatch is hereby retracted.
 
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Brand NameGORE MYCROMESH® BIOMATERIAL
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
Manufacturer (Section G)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
cheryl hawke
301 airport rd.
elkton, MD 
9285263030
MDR Report Key5948965
MDR Text Key54651932
Report Number3003910212-2016-00040
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K931150
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 10/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2016
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? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/14/2016 Patient Sequence Number: 1
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