No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, adhesions, inflammation and subsequent surgical intervention.The instructions-for-use supplied with the device lists adhesions, inflammation as possible complications.A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to specification.Should additional information be provided, a supplemental emdr will be submitted.Not returned.
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Attorney alleges that on or about (b)(6) 2012, the patient underwent surgery for the repair of an umbilical hernia.A non-bard/davol product was implanted to repair the hernia.It is alleged on (b)(6) 2013, the patient underwent revision surgery and a bard/davol composix kugel mesh was implanted to repair a hernia.It is alleged on or about (b)(6) 2015, the patient underwent further revision surgery and removal of the meshes.It is alleged that the patient has suffered and will continue to suffer severe and chronic pain, inflammation, adhesions, mesh detachment, and surgery to remove the meshes.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, pain and suffering for severe and permanent personal injuries sustained by the patient." attorney also alleges that the device was defective.
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