Product complaint # (b)(4).(b)(4).Device not returned.Additional information was requested and received.If further details are received at a later date a supplemental medwatch will be sent.Are photos available? photos were sent when complaint called in it was noted the patient had blistering and they were drained in the physician¿s office.Please describe any other medical or surgical intervention required to treat the reaction including start date and results.None what surgical preparation was used prior to, during, or after product use? chloraprep, with ioban drape.How was the product applied? per ifu.Has the patient demonstrated previous hypersensitivity or allergies to cyanoacrylate or formaldehyde? unknown.Has the patient had prior exposure to dermabond, prineo or other skin adhesives? unknown.Does the patient have allergies to medication, food, etc.? unknown.Was an allergy test performed? if so, please provide results.Unknown.Has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? unknown.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Not available.What is the physician¿s opinion as to the etiology of or contributing factors to this event? concerned but no other opinion expressed.What is the patient's current status? unknown.Surgeon¿s name? (b)(6).Product lot number? unavailable.Was a dressing placed over the incision? if so, what type of cover dressing was used? no dressing placed over the dermabond prineo.No device is available.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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