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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE SYNECOR PREPERITONEAL HERNIA MESH MESH, SURGICAL, POLYMERIC

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W. L. GORE & ASSOCIATES, INC. GORE SYNECOR PREPERITONEAL HERNIA MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problems Patient-Device Incompatibility (2682); Material Protrusion/Extrusion (2979)
Patient Problems Abdominal Pain (1685); Purulent Discharge (1812); Fistula (1862); Seroma (2069); Impaired Healing (2378); Post Operative Wound Infection (2446)
Event Date 02/07/2019
Event Type  Injury  
Event Description
Gore synecor preperitoneal abdominal mesh used in the repair of a large ventral hernia. Started experiencing problems on day 1. Had purulent drainage in my drain that did not clear up. Drain was pulled about 3 weeks post op. Developed a seroma that burst through an older incision line in abdomen below navel. The date the seroma burst, imaging was done which stated findings were "highly suspicious" for a chronic mesh infection. Was started on antibiotics (doxycycline. ) the wound still did not close. Experienced chronic drainage for over 2 years despite antibiotics and proper wound care. I have experienced chronic abdominal pain that has nearly destroyed my livelihood. Developed a fistula that was surgically excised in (b)(6) 2021, however the infection spread. I developed two additional seromas that burst through my navel and again through the incision below my navel. Insisted on infectious disease referral. Was started on rifampin which did not help the wound. Tried wound vac therapy which did not help. Eventually the mesh became visible to the naked eye. Sought other expert opinions who recommended the mesh be removed. Most of the gore synecor mesh was removed. Some remnants remain in my abdominal wall. Phasix was used in its place. Fda safety report id# (b)(4).
 
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Brand NameGORE SYNECOR PREPERITONEAL HERNIA MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
MDR Report Key12407038
MDR Text Key269658264
Report NumberMW5103647
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/31/2021 Patient Sequence Number: 1
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