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, recurrence, seroma, inflammation and surgical intervention.
The instructions-for-use supplied with the device lists seroma and inflammation as possible complications.
A review of the manufacturing records was performed 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) 2005, the patient underwent a repair of a supraumbilical hernia.
A bard/davol ventralex mesh was implanted.
On or about (b)(6) 2016, the patient underwent surgery to revise the failed ventralex mesh and a non-bard davol mesh was implanted during the procedure.
On or about (b)(6) 2020, the patient underwent surgery to revise the failed mesh products.
Attorney alleges that the patient experiences and/or continue to experience severe and chronic pain, inflammation, consistent bulging filled with fluid, recurrence, and tenderness.
Attorney alleges general allegations for ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.
" it is also alleged that the device was defective.
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