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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 1DLMCP03
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 03/03/2021
Event Type  Injury  
Manufacturer Narrative
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. " the gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed. 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 open ventral hernia repair on (b)(6) 2006 whereby a gore® dualmesh® plus biomaterial was implanted. The complaint alleges that on (b)(6) 2021, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: infection, adhesions, recurrence, pain. 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)
MEDICAL WOODY MOUNTAIN B/P
3750 w. kiltie lane
flagstaff AZ 86005
Manufacturer Contact
vanessa rodriguez
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key14429556
MDR Text Key291931795
Report Number2017233-2022-02927
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00733132601103
UDI-Public00733132601103
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 09/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/19/2007
Device Model Number1DLMCP03
Device Catalogue Number1DLMCP03
Was Device Available for Evaluation? No
Date Manufacturer Received08/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/19/2005
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: 05/18/2022 Patient Sequence Number: 1
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