Product complaint # (b)(4).Attempts to obtain the following information has been performed but not received.If the further details or the device are received at a later date a supplemental medwatch will be sent ¿ what is the procedure date? ¿ what date did the reaction occur on? ¿ what does the reaction look like and how large of an area does the reaction cover? ¿ do you have any pictures of the reaction? ¿ was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.¿ what is the most current patient status? ¿ can you identify the lot number of the product that was used? ¿ was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? it was noted that rx cream was prescribed, please provide details.Please describe how was the adhesive was applied.What prep was used prior to, during or after prineo 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? were any patch or sensitivity tests performed? patient demographics: initials / id, gender, age or date of birth; bmi patient pre-existing medical conditions (ie.Allergies, history of reactions) does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails) was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? additional information: please note that in the internal call the local team informed us that the adhesive is being left on the patients for four weeks.The patients typically did not present with skin reactions until after it was removed.The representatives also stated that the individuals applying the adhesive sometimes used their gloved finger tip to spread the adhesive on the mesh.Note: events reported on mw# 2210968-2020-06880 and mw#.
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