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U.S. Department of Health and Human Services

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

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W.L. GORE & ASSOCIATES GORE DUALMESH PLUS BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1DLMCP06
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problems Hernia (2240); Not Applicable (3189); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(b)(4). (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) 2008 whereby a gore® dualmesh® plus biomaterial was implanted. The complaint states that on an unknown date, an additional procedure was performed. There was no report of device removal. It was reported the patient alleges the following injuries: recurrent hernia, mesh failure, additional surgery. Additional event specific information was not provided.

 
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Brand NameGORE DUALMESH PLUS 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 Key8266789
MDR Text Key133717501
Report Number3003910212-2019-00013
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
Report Date 01/06/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/22/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2010
Device MODEL Number1DLMCP06
Device Catalogue Number1DLMCP06
Device LOT Number05496464
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 Manufactured09/20/2007
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: 01/22/2019 Patient Sequence Number: 1
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