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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 1DLMC06
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 11/03/2015
Event Type  Injury  
Event Description
It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2014 whereby a gore® dualmesh® biomaterial was implanted. The complaint alleges that on november 3, 2015, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: fistula, adhesions, infection, pain. Additional event specific information was not provided.
 
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. ".
 
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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
vanessa rodriguez
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key14431299
MDR Text Key291977154
Report Number3003910212-2022-01351
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00733132600991
UDI-Public00733132600991
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 08/24/2022
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 Date01/31/2018
Device Model Number1DLMC06
Device Catalogue Number1DLMC06
Was Device Available for Evaluation? No
Date Manufacturer Received07/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/18/2013
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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