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Model Number 1DLMCP04 |
Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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Patient Problems
Pain (1994); Hernia (2240); Not Applicable (3189); No Code Available (3191)
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Event Date 05/14/2013 |
Event Type
Injury
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Manufacturer Narrative
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(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.
¿.
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Event Description
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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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Search Alerts/Recalls
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