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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE BIOA TISSUE REINFORCEMENT MESH, SURGICAL, POLYMERIC

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W.L. GORE & ASSOCIATES GORE BIOA TISSUE REINFORCEMENT MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number HH0710
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/15/2018
Event Type  Injury  
Manufacturer Narrative

Additional patient code: (b)(4). Product identification records for the alleged gore device was not provided. Therefore, a review of the manufacturing records could not be performed. (b)(6). It should be noted that the gore® bio-a® tissue reinforcement 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 hiatal hernia repair on (b)(6) 2016 whereby a ¿gore bioabsorbable mesh¿ was implanted. The complaint alleges that on (b)(6) 2018, an additional procedure was performed ¿¿because mesh contracted allowing adhesions, recurrent hiatal hernia, and chest pain. Adhesions were taken down and a new phasix mesh had to be placed. ¿ it was reported the alleged ¿gore bioabsorbable mesh¿ was not explanted during this procedure. It was reported the patient alleges the following product deficiencies: contraction, adhesions, and recurrence. Additional event specific information was not provided.

 
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Brand NameGORE BIOA TISSUE REINFORCEMENT
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 Key8000769
MDR Text Key124860004
Report Number3003910212-2018-00094
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
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/24/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/24/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2019
Device Catalogue NumberHH0710
Device LOT Number14762803
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 Manufactured02/10/2016
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: 10/24/2018 Patient Sequence Number: 1
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