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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 1DLMCP04
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problems Pain (1994); Hernia (2240); Not Applicable (3189); No Code Available (3191)
Event Date 05/14/2013
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 incisional hernia repair on (b)(6) 2012, whereby a gore® dualmesh® plus biomaterial was implanted. The complaint alleges that on (b)(6) 2013, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: pain, bulge, recurrent hernia, removal of mesh, 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
marcos ayala
1500 n. 4th street
9285263030
MDR Report Key8377783
MDR Text Key137393747
Report Number3003910212-2019-00041
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 01/27/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/28/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2014
Device MODEL Number1DLMCP04
Device Catalogue Number1DLMCP04
Device LOT Number8910390
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 Manufactured02/03/2011
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: 02/28/2019 Patient Sequence Number: 1
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