The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.
Product was used for therapeutic treatment.
The patient underwent a laparoscopic parastomal hernia repair using composite mesh with enterolysis and mobilization of small bowel.
She had revision surgery 1 years and 8 months post-surgery.
The patient experienced multiple surgical revisions, recurrent hernia, incarcerated small bowel inside of a large parastomal hernia, adhesions, bowel stuck to hernia sac, relocation of stoma.
Please also reference pe# (b)(4).
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