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, hematoma, pain and subsequent surgical intervention.The instructions-for-use (ifu) supplied with the device lists hematoma and hernia recurrence 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 (b)(6) 2018, the patient was implanted with a bard mesh (bard flat mesh) in the course of ventral hernia repair surgery.It is alleged that further to the implantation with the product, the patient suffered the development of pain, swelling, hernia recurrence, hematoma and necessitating 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.
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