Product complaint # (b)(4).Additional information received: did the patient experience a post-op device malfunction? no.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? yes.Did the patient require revision surgery or hardware removal? no.If no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions? antihistamines.Patient status/ outcome / consequences.Yes.Is the patient part of a clinical study.Unknown.Device property of? none.Device in possession of? no.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.Feedback from the surgeon, dr.(b)(6).I had personally followed up with the surgeon on monday (b)(6) 2022 and she had nothing to report at the time.Additional information has been requested however not received to date.If further details are received at a later date a supplemental medwatch will be sent.Please review the complaints as the events appear similar, check for duplication error.Is a photo available of the patient reaction? what was the procedure date? what date /day post op was the reaction noted? please describe how was the adhesive was applied.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? 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) has the patient used or been 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? current patient status.Product not available for return.
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