The initial reporter's complete address is (b)(6).
Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: please see the attached file for information ascertained from the medical records.
It should be noted that the gore® synecor intraperitoneal 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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It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2007 whereby a gore® dualmesh® plus biomaterial was implanted.
The complaint alleges that on(b)(6) 2017, an additional procedure occurred whereby the gore device was explanted.
It was reported the patient alleges the following injuries: mesh removal, pain, adhesions, wound vac, additional surgery.
Additional event specific information was not provided.
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