Product complaint # (b)(4).Additional information provided: did the patient experience a post-op device malfunction? no.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? yes.Did the patient require revision surgery or hardware removal? no.If no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions? dermabond prineo was removed and patient was treated with topical steroid.Patient status/ outcome / consequences: yes.Patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? allergic contact dermatitis was detected after second exposure to dermabond prineo after performing tkr on the second knee., was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: yes.If yes, describe: topical steroids was prescribed.Is the patient part of a clinical study: unknown.Device property of: none.Device in possession of: none.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.What was the procedure date? what date /day post op was the reaction noted? please describe how was the adhesive was applied.What prep was used prior to, during or after adhesive 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)? current patient status.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.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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