(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: 1.What is the procedure name and initial procedure date? -ulna nerve decompression and translocation - (b)(6) 2017.2.What date did the reaction occur on? -within first 3-5 days.3.What does the reaction look like and how large of an area does the reaction cover? -please see picture - it was swollen, red and bubbly - blisters.4.Do you have any pictures of the reaction? -yes.5.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.-silver nitrate cream and hydrocortisone cream.6.What is the most current patient status? -patient says that area of incision or operation site is very sensitive still.7.Can you identify the product code and lot number of the product that was used? -prineo - code not known, lot unknown.
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