(b)(4).The following information was requested and received: date of the total knee replacement procedure? unknown.It was noted that both topical and oral steroids were administered, was the reaction treated in any other manner (product removed; reoperation; reclosure; other prescription)? if so, please clarify.Product removed before administering steroids.Please indicate any medical or surgical interventions performed.None.Please describe how was the adhesive was applied on the tape.Single layer with excess liquid wiped off after drying.What prep was used prior to, during or after prineo use? unknown.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown.Is the patient hypersensitive to pressure sensitive adhesives? unknown.Were any patch or sensitivity tests performed? unknown.What is the physicians opinion of the contributing factors to the reaction? dr feels there has been a change in formulation or tape.What is the most current patient status? unknown.Is the product or representative sample (product from the same lot number) available for evaluation? no.Patient demographics: initials / id; age or date of birth; bmi; gender.Unknown.Patient pre-existing medical conditions (ie.Allergies, history of reactions).Unknown.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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