(b)(4).Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Are photos available of the reaction? date of surgical procedure? if product was removed, date of removal? does the patient have allergies to medication, food, etc.? was an allergy test performed? if so, please provide results.What surgical preparation was used prior to, during, or after product use? please describe how was the product applied? has the patient demonstrated previous hypersensitivity or allergies to cyanoacrylate or formaldehyde? has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? has the patient had prior exposure to dermabond, prineo or other skin adhesives? please describe type and dosage to treat the reaction including start date and results.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure other relevant patient history/concomitant medications? surgeon¿s name? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? product lot number? no product available for return.
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