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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
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 10/19/2010
Event Type  Injury  
Manufacturer Narrative

Product identification records for the alleged gore device were not provided. Therefore, a review of the manufacturing records could not be performed. 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. ".

 
Event Description

It was reported to gore that the patient underwent incisional hernia repair on (b)(6) 2010 whereby a gore® dualmesh® biomaterial was implanted. The complaint alleges that on (b)(6) 2010, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: chronic pain, adhesion, hernia recurrence, mesh erosion and swelling abdomen. 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
heidi womble
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key10877039
MDR Text Key217440599
Report Number3003910212-2020-01136
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK992189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/30/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/20/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 11/20/2020 Patient Sequence Number: 1
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