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U.S. Department of Health and Human Services

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

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W.L. GORE & ASSOCIATES GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number GKFR2030
Device Problem Insufficient Information (3190)
Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Post Operative Wound Infection (2446)
Event Date 09/28/2017
Event Type  Injury  
Manufacturer Narrative

(b)(6). (b)(4). It should be noted that the gore® synecor intraperitoneal biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, pain, exposure (extrusion), bowel obstruction and recurrence. As with any surgical procedure, there are always risks of complications for surgical repair of hernias, with or without mesh, these may include but are not limited to, infection, inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision/resurgery, device contraction, fever, hernia recurrence. ¿ the gore® synecor intraperitoneal biomaterial instructions for use also states: ¿strict aseptic techniques should be followed. When operative infection is suspected, dissection of involved tissues should be considered. If an infection develops, it should be treated aggressively. An unresolved infection may require removal of the material. ¿.

 
Event Description

It was reported to gore that the patient underwent laparoscopic incisional hernia repair on (b)(6) 2017 whereby a gore® synecor intraperitoneal was implanted. The complaint alleges that on (b)(6) 2017, the patient developed wound infection with dehiscence. The complaint alleges that on (b)(6) 2018, an additional procedure occurred whereby excisional debridement of wound edges with fasciocutaneous flap creation occurred. The complaint alleges that on (b)(6) 2018, additional procedures occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: wound infection, wound dehiscence, wound vac, additional surgical procedure, mesh removal, chronic open wound, scar, purulent drainage, inflamed soft tissue with associated mesh, mesh contraction. Additional event specific information was not provided.

 
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Brand NameGORE® SYNECOR INTRAPERITONEAL 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
katheryn fox
9285263030
MDR Report Key8912035
MDR Text Key155190500
Report Number3003910212-2019-00257
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK152609
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/18/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/20/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/07/2019
Device Catalogue NumberGKFR2030
Device LOT Number15690535
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/07/2016
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: 08/20/2019 Patient Sequence Number: 1
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