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(b)(4).
Additional information has been requested however not received.
If further details are received at a later date a supplemental medwatch will be sent.
What date did the reaction occur on? what does the reaction look like and how large of an area does the reaction cover? if medication was required, please clarify if it was prescription strength.
1.
Are photos available of the reaction? 2.
Date of surgical procedure? 3.
If product was removed, date of removal? 4.
What medical and/or surgical intervention or treatment was performed to address the reaction with blisters? 5.
Was a procedure performed to drain the blisters? 6.
Does the patient have allergies to medication, food, etc.
? 7.
Was an allergy test performed? if so, please provide results.
8.
What surgical preparation was used prior to, during, or after product use? 9.
Please describe how was the product applied? 10.
Has the patient demonstrated previous hypersensitivity or allergies to cyanoacrylate or formaldehyde? 11.
Has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? 12.
Has the patient had prior exposure to dermabond, prineo or other skin adhesives? 13.
Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure 14.
Other relevant patient history/concomitant medications? 15.
Surgeon¿s name? 16.
What is the physician¿s opinion as to the etiology of or contributing factors to this event? 17.
What is the patient's current status? 18.
Product lot number? no product available for return.
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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