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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1DLMC03
Device Problem Insufficient Information (3190)
Patient Problems Abscess (1690); Fistula (1862); Unspecified Infection (1930)
Event Date 01/17/2020
Event Type  Injury  
Manufacturer Narrative
It should be noted that the gore® dualmesh® 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® 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 incarcerated incisional hernia repair on (b)(6) 2018, whereby a gore® dualmesh® biomaterial was implanted. The complaint alleges that on (b)(6) 2020, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: abscess, debridement, fistula, incision and drainage, infection, mesh removal, pain. Additional event specific information was not provided.
 
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Brand NameGORE® DUALMESH® 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
jorja nackard
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key12206828
MDR Text Key264111249
Report Number3003910212-2021-01269
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992189
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 12/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1DLMC03
Device Catalogue Number1DLMC03
Was Device Available for Evaluation? No
Date Manufacturer Received01/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/16/2018
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: 07/21/2021 Patient Sequence Number: 1
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