(b)(4).
The initial reporter's complete address is (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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It was reported to gore that the patient underwent open incisional hernia repair on (b)(6) 2009 whereby a gore dualmesh® plus biomaterial was implanted.
It was reported the patient alleges the following injuries: abdominal pain, small bowel obstruction, adhesions, multiple hernia recurrences, mesh revision.
Additional event specific information was not provided.
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