(b)(4).The following information has been requested however no response has been 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.What is the procedure date? what date did the reaction occur on? 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? is the product involved in the event or a representative sample (product from the same lot number) available for evaluation? does the reaction occur in both areas where adhesive was applied (breast(s) and abdomen)? are any photos of the reaction available? 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) what is the most current patient status? note: events reported on mw# 2210968-2020-08535.
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