(b)(4).The following information was requested and obtained: what is the procedure date? not known.What date did the reaction occur on? not known.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.Dermatologist appointments and steroid prescription on patient.What is the most current patient status? recovered can you identify the product code and lot number of the product that was used? clr222us, lot#s not known.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? not known.The following information was requested however, not received.If the further details are received at a later date a supplemental medwatch will be sent.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).Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? informed the product will not be returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.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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