Product identification records for the alleged gore device was not provided.
Therefore, a review of the manufacturing records could not be performed.
The initial reporter's complete address is ketterer (b)(6).
It should be noted that although the brand name and lot# of a gore device has not been provided, the instructions for use for the vast majority of gore¿s eptfe patch products that are indicated for the reconstruction of soft tissue deficiencies include the following warnings among others: ¿possible 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 incisional hernia repair on an unknown date in (b)(6) 2000 whereby an alleged "gore-tex" device was implanted.
It was reported to gore that the patient underwent open ventral repair on (b)(6) 2002 whereby an dualmesh® biomaterial was implanted.
The complaint alleges that on (b)(6) 2002 an additional procedure was performed whereby explant of the gore device was performed.
The complaint alleges that on (b)(6) 2013 an additional procedure was performed whereby explant of the gore device was performed.
It was reported the patient alleges the following injuries: abdominal pain, small bowel obstruction, small bowel resection, hernia recurrence, mesh removal.
Additional event specific information was not provided.
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