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U.S. Department of Health and Human Services

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

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W.L. GORE & ASSOCIATES GORE DUALMESH BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1DLMC03
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problems Hematoma (1884); Pain (1994); Obstruction/Occlusion (2422); Not Applicable (3189)
Event Date 06/18/2015
Event Type  Injury  
Manufacturer Narrative

(b)(4). (b)(6). It should be noted that the gore dualmesh® biomaterial instructions for use includes warnings and 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 laparoscopic ventral hernia repair on (b)(6) 2010 whereby a gore dualmesh® biomaterial was implanted. The complaint alleges that on (b)(6) 2015, an additional procedure was performed whereby the gore device was explanted. It was reported the patient alleges the following injuries: abdominal pain, hematoma, hernia recurrence, small bowel obstruction, mesh removal. Additional event specific information and medical records have been requested.

 
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Brand NameGORE DUALMESH BIOMATERIAL
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
Manufacturer (Section G)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
kathy titus
1500 n. 4th street
flagstaff, AZ 
9285263030
MDR Report Key7641305
MDR Text Key112442743
Report Number3003910212-2018-00051
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
Reporter Occupation OTHER CAREGIVERS
Type of Report Initial,Followup,Followup
Report Date 08/18/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/27/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/01/2014
Device MODEL Number1DLMC03
Device Catalogue Number1DLMC03
Device LOT Number06589185
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/02/2009
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: 06/27/2018 Patient Sequence Number: 1
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