(b)(4).Attempts to obtain the following information have been made but not received.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.Is a photo of the reaction available? what is the procedure name? it was noted the reaction occurred on (b)(6) 2020, what is the procedure date? it was noted a steroid was prescribed, was there any other medical or surgical treatment provided? 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? 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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