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U.S. Department of Health and Human Services

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

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W.L. GORE & ASSOCIATES GORE DUALMESH PLUS BIOMATERIAL WITH CORDUROY MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1DLMCP06
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/2003
Event Type  Injury  
Manufacturer Narrative

(b)(6). It should be noted that the gore® dualmesh® plus 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) 2002, whereby a gore® dualmesh® plus biomaterial was implanted. The complaint alleges that on (b)(6) 2003, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: removal of mesh, additional surgery. Additional event specific information was not provided.

 
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Brand NameGORE DUALMESH PLUS BIOMATERIAL WITH CORDUROY
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
Manufacturer (Section G)
MEDICAL WOODY MOUNTAIN B/P
3750 w. kiltie lane
flagstaff AZ 86005
Manufacturer Contact
marcos ayala
1500 n. 4th street
9285263030
MDR Report Key8442158
MDR Text Key139537003
Report Number2017233-2019-00160
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK063435
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/23/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/21/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/02/2003
Device MODEL Number1DLMCP06
Device Catalogue Number1DLMCP06
Device LOT Number00751001
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/02/2001
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: 03/21/2019 Patient Sequence Number: 1
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