(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.Additional information was requested and the following was obtained: was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify: dermabond removed 1 week post-op can you identify the lot number of the product that was used? tba was the resolve topical cream prescribed or over the counter? prescribed.
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