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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE BIO-A TISSUE REINFORCEMENT MESH, SURGICAL, POLYMERIC

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W. L. GORE & ASSOCIATES, INC. GORE BIO-A TISSUE REINFORCEMENT MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number HH0710
Device Problem Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); No Code Available (3191)
Event Date 05/07/2014
Event Type  Injury  
Manufacturer Narrative

(b)(4). It should be noted that the gore® bio-a® tissue reinforcement instructions for use 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. " the gore® bio-a® tissue reinforcement instructions for use also states: ¿strict aseptic techniques should be followed. If an infection develops, it should be treated aggressively. An unresolved infection may require removal of the material. ".

 
Event Description

It was reported to gore that the patient underwent laparoscopic ventral hiatal hernia repair on (b)(6) 2010, (b)(6) 2017, and (b)(6) 2017, whereby gore® dualmesh® plus biomaterial and gore® bio-a® tissue reinforcement were implanted. The complaint alleges that on (b)(6) 2014, an additional procedure occurred whereby one of the gore devices were explanted. It was reported the patient alleges the following injuries: removal of gore mesh due to dense erosion and infection, gore mesh was stained throughout due to erosion, foul smell from the infected gore mesh, large portion of the stomach eroded to the gore mesh, gastrectomy due to mesh erosion, portion of gore mesh appeared dark and discolored, dense adhesions noted along the undersurface of the liver, primary repair of recurrent hiatal hernia defect. Additional event specific information was not provided.

 
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Brand NameGORE BIO-A TISSUE REINFORCEMENT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
heidi womble
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key11231914
MDR Text Key228856621
Report Number3003910212-2021-01158
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK033671
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 04/05/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/26/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2019
Device MODEL NumberHH0710
Device Catalogue NumberHH0710
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/21/2016
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: 01/26/2021 Patient Sequence Number: 1
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