(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following additional information was requested and received: is a photo available of the blister/reaction? not available.Name of surgery? caesarea.Date of surgery? not available.Describe the reaction (e.G.Blister/red/infected/mild¿) allergic reaction.What specific type of medical / surgical treatment was provided to treat the reaction? increased hospitalization, antibiotic, product lookup and handling of infected wounds.What prep was used prior to, during or after prineo use? surgical wound asepsis.How many layers of adhesive were used over during application? 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.What is the physicians opinion of the contributing factors to the reaction? the patient made allergic reaction to the product.Patient demographics: initials / id; age or date of birth; bmi: unknown.Patient pre-existing medical conditions (ie.Allergies, history of reactions): unknown.Was the patient exposed to similar products, such as artificial nails? unknown.Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? no, first time it's been used on the patient.To date no sample has been returned.If product is returned or further details are received at a later date a supplemental medwatch will be sent.
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It was reported a patient underwent a cesarean section on an unknown date and topical skin adhesive was used.The patient presented with blister, erythema, allergic skin reaction and burning at the site.The patient received treatment with prescription antibiotic, increased hospitalization and handling of infected wounds.Additional information has been requested.
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