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Product complaint # (b)(4).
Attempts to obtain the following information have been made, however not received to date.
Attempts have also been made to obtain the device.
To date the device has not been returned.
If further details are received at a later date a supplemental medwatch will be sent.
Name of procedure? date of procedure? date of reaction? was there any treatment provided (reoperation; reclosure; prescriptions; antibiotics prescribed) to address reaction? if so, please provide details.
Please indicate any medical or surgical interventions performed.
Please describe how was the adhesive was applied.
What prep was used prior to, during or after prineo use? was a dressing placed over the incision? if so, what type of cover dressing used? did the patient have prior experience with dermabond and this surgical glue in a prior procedure? 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; age or date of birth; bmi ; patient pre-existing medical conditions (ie.
Allergies, history of reactions) does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails).
Current patient condition? 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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.
Note: events reported via mw# 2210968-2020-04931, mw# 2210968-2020-04932, mw# 2210968-2020-04933.
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