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(b)(4).
Additional information: customer reference/po/service --> (b)(6) hospital, 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?--> topical steroids was prescribed to patient to manage allergic contact dermatitis, patient status/ outcome / consequences --> yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.
)?--> patient experience allergic contact dermatitis from exposure to dermabond prineo for the second time, was other medical intervention (e.
G.
X-rays, additional procedures, prescriptions, otc, revision) required: --> yes, if yes, describe --> topical steroids was prescribed to patient to manage allergic contact dermatitis, 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.
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.
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