Product complaint # (b)(4).Additional information was requested and the following was obtained: did the patient experience a post-op device malfunction? no, did the patient experience an adverse event? yes, did the patient require revision surgery or hardware removal? no, if no, was there any additional medical intervention required? removal of prineo and local steriods, patient status/ outcome / consequences yes, patient consequence description/was there a clinical outcome experienced by the patient? reported skin reaction, was other medical intervention required: yes, if yes, describe steroid cream, photos available? no.Can you confirm date/approx.How long did the reaction occur post op? noted approx.8-10 days post op.What prep was used prior to, during or after prineo use? chlorhexidine.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? not that dr was aware.Were any patch or sensitivity tests performed? no.What is the physician¿s opinion of the contributing factors to the reaction? allergic chemical reaction to the product.Patient demographics: initials / id; age or date of birth; bmi; gender ¿ will try to obtain patient pre-existing medical conditions (ie.Allergies, history of reactions) - will try to obtain.For female patients ask: was the patient exposed to similar products, such as artificial nails? patient had had prineo used on her 6 months earlier without issue was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? see above, patient had had prior use of prineo.What is the most current patient status? rash has settled.Dr also reported patient now approximately 3 weeks post operation, but could not recall on the phone the day of the procedure.He also noted that the patient was likely to have been operated on at different hospital but couldn't be sure to date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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