(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.(b)(4) submitted for adverse event which occurred on (b)(6) 2015.(b)(4) submitted for adverse event which occurred on (b)(6) 2015.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2005 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2015 during which the surgeon noted he encountered a large amount of old purulent material.It was reported that the patient underwent an excision of seroma cavity and drain placement on (b)(6) 2015.It was reported that the patient experienced infection, severe pain, seroma, scarring, inflammation, loss of appetite, stress and anxiety.No additional information was provided.
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