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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. GORE DUALMESH PLUS BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1DLMCP06
Device Problem Insufficient Information (3190)
Patient Problems Hernia (2240); No Code Available (3191)
Event Date 11/09/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)]. It should be noted that the gore® dualmesh® plus biomaterial instructions for use 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, and recurrence. ".
 
Event Description
It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2015 whereby a gore® dualmesh® plus biomaterial was implanted. The complaint alleges that on (b)(6) 2017, an additional procedure occurred. It was reported the patient alleges the following injuries: hernia recurrence; chronic pain; adhesions, mesh disruption. Additional event specific information was not provided.
 
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Brand NameGORE DUALMESH PLUS BIOMATERIAL
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
megan reigh
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key10576558
MDR Text Key208226902
Report Number3003910212-2020-01089
Device Sequence Number1
Product Code FTL
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K063435
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 03/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2017
Device Model Number1DLMCP06
Device Catalogue Number1DLMCP06
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/30/2015
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: 09/23/2020 Patient Sequence Number: 1
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