Based on the information provided at this time no conclusion can be made as to the degree to which the bard soft mesh may be causing or contributing to the patient's reported condition.The patient's doctor is being provided with a mesh sample for reactivity testing.At this time the testing has not been completed.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this manufacturing lot of 199 units.Lot was released for distribution in july, 2018.Should additional information be provided, a supplemental emdr will be submitted.Remains implanted.
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