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, subsequent surgical intervention, bulging (hernia recurrence), nerve damage and inflammation.
The instructions-for-use supplied with the device lists hernia recurrence and 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) 2014, the patient underwent repair for a right groin hernia and was implanted with a non-bard/davol mesh.
On or about (b)(6) 2018, the patient underwent surgery for the repair of recurrent right groin hernia and was implanted with a bard/davol perfix plug.
On or about (b)(6) 2019, the patient underwent revision surgery due to the hernia mesh device.
It is also alleged that the patient underwent the removal of the non-bard/davol mesh.
It is alleged that the patient experienced and/or continues to experience severe and chronic pain/discomfort, inflammation, significant scarring, bulging mass and neurectomy of genital branch of genitofemoral nerve.
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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