Product complaint # (b)(4).Additional information has been requested and obtained.If further details are received at a later date a supplemental medwatch will be sent.All responses are unknown: name of orthopedic procedure performed? unknown.Date of procedure? unknown.Date of reaction? is a photo available of the reaction? it was noted that a prescription oral and topical steroids were given.Were there any other medical or surgical interventions performed? unknown.Please describe how the adhesive was applied.Unknown.What prep was used prior to, during or after prineo use? unknown.Was a dressing placed over the incision? if so, what type of cover dressing used? unknown.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown.Is the patient hypersensitive to pressure sensitive adhesives? unknown.Were any patch or sensitivity tests performed? unknown.Patient demographics: initials / id, gender, age or date of birth; bmi.Unknown.Patient pre-existing medical conditions (ie.Allergies, history of reactions) unknown.Has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? unknown.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown.Can you identify the product lot number of the product that was used? unknown.What is the current status of the patient? unknown.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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It was reported a patient underwent an unknown orthopedic procedure on an unknown date and topical skin adhesive was used.Post operatively, the patient experienced a rash, redness and blistering.Patient was referred to a dermatologist who prescribed oral and topical steroids.Patient current status is good.Additional information has been requested.
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