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Product complaint: (b)(4).Additional information: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Additional information has been requested and received.Attempts to obtain the device have been made.What is the procedure date (dd/mm/yyyy)? information requested but no response information.What date did the reaction occur on (dd/mm/yyyy)? the patient had the dressing on for 3 weeks - date of reaction not disclosed.What does the reaction look like and how large of an area does the reaction cover? picture.Do you have any pictures of the reaction? attached - this is the patient at 6 weeks post op.Was there any medical or surgical intervention performed (prodinformaton; re-operation; re-closure; prescription medication)? if so, please specify.- product removed at 3 weeks and antihistamines prescribed.If medication was required, please clarify if it was prescription strength.Information not available.Can you identify the lot number of the product that was used? information not available.What is the most current patient status? unknown.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? no.Additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Description of event, symptoms, manifestation of reaction infection.Name of surgery? was any surgical intervention performed? when was the prineo product removed from the patient? were any cultures taken? results? please describe how was the adhesive was applied.How was the wound cleaned and dried prior to prineo application? what prep was used prior to, during or after adhesive use? was a dressing placed over the incision? if so, what type of cover dressing used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? does the patient have allergies to medication, food, etc.? was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? patient demographics: initials / id, gender, age or date of birth; bmi patient pre-existing medical conditions (ie.Allergies, history of reactions) has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? current patient status.Name of surgeon? what is the physician¿s opinion as to the etiology of or contributing factors to this event? is product available to return for analysis.No product is available for return.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.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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