Product complaint # (b)(4).The following information was requested and was informed: there is no further information available for this complaint.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.Date of procedure? procedure name? what was the date of the reaction, day post op? it was noted steroid was prescribed, please provide type and dosage.What other medical and or surgical intervention was provided to address the issue? 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? 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) does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails) was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? can you identify the lot number of the product that was used? current patient status.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
It was reported a patient underwent an unknown procedure on and unknown date in 2020 and topical skin adhesive with mesh was used.Post operatively, the patient had acute dermatitis reaction to adhesive at follow up.A prescription for steroid to resolve issue, no other information is available.Additional information has been requested.
|