Product complaint # (b)(4).Additional information was requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Procedure name? procedure date? what was the date of the reaction, day post op? it was described that ¿the area was treated with antibiotics and steroids¿.Were these prescription strengths for each patient? 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: id, gender, age or date of birth; bmi? has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo/dermabond skin adhesive used on the patient in a previous surgery or wound closure? do you have the product code and /or lot number used? current patient status.Is there a photo available of the patient¿s reaction (please reference pt/pc)? no device available for analysis.Note: events reported on mw#: 2210968-2021-07795, 2210968-2021-07796, 2210968-2021-07797, 2210968-2021-07798, 2210968-2021-07799, 2210968-2021-07800, 2210968-2021-07808, 2210968-2021-07803, 2210968-2021-07804, 2210968-2021-07807, and 2210968-2021-07806.
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