(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: what was the name of the procedure? -total knee or total hip.Please describe how was the adhesive applied on the tape? - technique applied says she used about a quarter of the liquid and sometime she would rub/ spread it in with her finger.Is the patient hypersensitive to pressure sensitive adhesives?-unknown is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? - no.Were any patch or sensitivity tests performed? - they do not do that.Do you have the lot number involved? -no.What is the physicians opinion of the contributing factors to the rash/ blister? - unknown.Patient demographics: initials / id; age or date of birth; bmi; gender? - no.Patient pre-existing medical conditions (ie.Allergies, history of reactions)? -no.What is the most current patient status? patient may have been seen at their 6 week appointment and it was cleared up.Is the product or representative sample (product from the same lot number) available for evaluation? -no.
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