Product complaint # (b)(4).The following information has been requested and obtained.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.Was there any medical or surgical intervention performed to threat the reaction (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? yes.If so, please clarify.Patient wan put on additional abx-keflex and bactrim last week.What is the most current patient status? pat was admitted to the hospital in cheyenne on (b)(6) 2020 and released on 12.20.20.While in the hospital they gave him steroids and iv bene drill and the patient also suspected mrsa infection.Can you identify the lot number of the product that was used? no.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? no.The following information has been requested however 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.Please describe how 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) has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? what is the current status of the patient?.
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