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Model Number 1DLMC02 |
Device Problems
Use of Device Problem (1670); Microbial Contamination of Device (2303); Insufficient Information (3190); Patient Device Interaction Problem (4001)
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Patient Problems
Erosion (1750); Fistula (1862); Unspecified Infection (1930); Nausea (1970); Pain (1994); Vomiting (2144)
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Event Date 04/02/2007 |
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® 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 parastomal hernia repair on (b)(6) 2003 whereby a gore dualmesh® biomaterial device was implanted.
It was reported that on (b)(6) 2005, laparoscopic repair of a parastomal hernia was performed whereby another gore dualmesh® biomaterial device was implanted.
According to the report, the patient underwent laparoscopic ventral hernia repair on (b)(6) 2006 whereby a third gore dualmesh® biomaterial device was implanted.
The complaint alleges that on (b)(6) 2007, the gore devices were explanted, and two parastomal mesh devices were implanted.
It was reported the patient alleges the following injuries: abdominal pain, nausea and vomiting, dense abdominal adhesions, adhesions to small bowel and colon, multiple bowel obstructions, small bowel perforation, hernia recurrence, additional surgeries to repair hernia, abdominal abscess, open draining wound, and mesh removal.
Additional event specific information and medical records were not provided but have been requested.
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Search Alerts/Recalls
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