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Model Number 1DLMCP02 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Unspecified Infection (1930); No Code Available (3191)
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Event Date 05/07/2014 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (¿g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (¿g/cm3)].
It should be noted that the gore® dualmesh® plus biomaterial 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® dualmesh® plus biomaterial 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.
".
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Event Description
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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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Search Alerts/Recalls
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