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(b)(4).
Additional information: did the patient experience a post-op device malfunction? unknown, 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? topical steroids and antihistamines was prescribed to patient for the allergic reaction.
Patient status/ outcome / consequences? yes.
Patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.
)? patient experienced allergic contact dermatitis from second use of dermabond prineo, the skin surrounding the wound where prineo was applied was red and itchy.
Was other medical intervention (e.
G.
X-rays, additional procedures, prescriptions, otc, revision) required: yes.
If yes, describe.
Topical steroids and antihistamines were prescribed.
Additional information has been requested however not received to date.
If further details are received at a later date a supplemental medwatch will be sent.
Were topical steroids prescription strength? is a photo available of the patient reaction? 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.
Product not available for return.
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