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, hernia recurrence, cellulitis, adhesions and subsequent surgical intervention.The instructions-for-use (ifu) supplied with the device lists hernia recurrence, inflammation and adhesions 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.
|
Attorney alleges that on (b)(6) 2011, the patient underwent surgery for an inguinal hernia repair and a bard/davol perfix plug was implanted.It is alleged that further to the implantation of the product, the patient suffered the development of cellulitis, inflammation, pain, adhesions, and hernia recurrence, necessitating further reparative surgery.It is alleged that the patient has suffered injuries, losses and damages resulting from numerous defects in the product that create an unreasonably high risk of injury with severe permanent adverse health consequences.Attorney alleges that the patient experienced severe pain and suffering, including chronic pain.It is also alleged the patient was treated with a course of hospitalization, diagnostic imaging, revision surgery, serum testing, antibiotics, analgesics and rest.Attorney alleges that the patient will require further invasive repair surgery, physiotherapy, rehabilitation and will continue to require other forms of medical care.It is also alleged that the device was defective.
|