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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 1DLMC07
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 05/20/2014
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 laparoscopic incisional hernia repair on (b)(6) 2002 whereby two gore® dualmesh® biomaterial devices were implanted, and additionally on (b)(6) 2005 whereby another gore® dualmesh® biomaterial was implanted. The complaint alleges that on (b)(6) 2014 an additional procedure occurred whereby a gore device was partially explanted. It was reported the patient alleges the following injuries: hernia recurrence, non adherence, infection, lack of incorporation, partial explant. 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)
MEDICAL WOODY MOUNTAIN B/P
3750 w. kiltie lane
flagstaff AZ 86005
Manufacturer Contact
heidi womble
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key11767940
MDR Text Key248815953
Report Number2017233-2021-01948
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,Followup
Report Date 05/27/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/04/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/09/2010
Device MODEL Number1DLMC07
Device Catalogue Number1DLMC07
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/10/2005
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: 05/04/2021 Patient Sequence Number: 1
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