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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 1DLMC06
Device Problems Microbial Contamination of Device (2303); Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Nausea (1970); Pain (1994); Vomiting (2144)
Event Date 04/02/2007
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 parastomal hernia repair on (b)(6) 2003 whereby a gore dualmesh® biomaterial device was implanted. It was reported that on (b)(6) 2005, laparoscopic repair of a parastomal hernia was performed whereby another gore dualmesh® biomaterial device was implanted. According to the report, the patient underwent laparoscopic ventral hernia repair on (b)(6) 2006 whereby a third gore dualmesh® biomaterial device was implanted. The complaint alleges that on (b)(6) 2007, the gore devices were explanted, and two parastomal mesh devices were implanted. It was reported the patient alleges the following injuries: abdominal pain, nausea and vomiting, dense abdominal adhesions, adhesions to small bowel and colon, multiple bowel obstructions, small bowel perforation, hernia recurrence, additional surgeries to repair hernia, abdominal abscess, open draining wound, and mesh removal. Additional event specific information and medical records were not provided but 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)
MEDICAL WOODY MOUNTAIN B/P
3750 w. kiltie lane
flagstaff AZ 86005
Manufacturer Contact
kathy titus
9285263030
MDR Report Key7639155
MDR Text Key112381533
Report Number2017233-2018-00338
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Caregivers
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/15/2011
Device Model Number1DLMC06
Device Catalogue Number1DLMC06
Device Lot Number04380897
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 Manufactured05/16/2006
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: 06/26/2018 Patient Sequence Number: 1
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