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U.S. Department of Health and Human Services

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

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W.L. GORE & ASSOCIATES GORE DUALMESH PLUS BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1DLMCP03
Device Problems Contamination (1120); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Hernia (2240)
Event Date 12/01/2011
Event Type  Injury  
Manufacturer Narrative

The patient reported she had a gallbladder surgery in 2010. The patient reported this is what caused the initial hernia. She stated the sutures broke loose, the hernia got bigger and that is when the mesh was placed. The gore dualmesh® plus biomaterial instructions for use (ifu)state: as with any surgical procedure, there are always risks of complications in surgical repair of soft tissue deficiencies, with or without mesh. Complications may include but are not limited to, infection, inflammation,adhesion, fistula formation, seroma formation,perforation, wound dehiscence, wound complications,pain, bowel obstruction, ileus, revision/re-intervention,fever and recurrence.

 
Event Description

The following was reported to gore via a voluntary medwatch (mw5089651): infected abdomen from mesh implant, multiple surgeries, drain tubes, pic lines, wound vacs, hospital stays, wound center. Per the voluntary medwatch the device was explanted on (b)(6) 2011.

 
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Brand NameGORE DUALMESH PLUS 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
angela brown
1500 n. 4th street
9285263030
MDR Report Key9220824
MDR Text Key163707153
Report Number3003910212-2019-00437
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK063435
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/22/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2013
Device MODEL Number1DLMCP03
Device Catalogue Number1DLMCP03
Device LOT Number8295141
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 Manufactured06/29/2010
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: 10/22/2019 Patient Sequence Number: 1
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