(b)(4).Additional information has been requested and obtained.Do you have any pictures of the reaction? no.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication? if so, please specify.N/a.If medication was required, please clarify if it was prescribed or purchased over-the-counter.N/a.What is the most current patient status? full recovery.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? additional information provided by rn: our patients usually wear it for 4-6 weeks post op and may shower with it insitu once their drains are removed.I am pleased to say - all patients are fine now.We have occasionally seen reactions using prineo in the past and a few times - when a patient has had a secondary revisional surgery ( but did not react the first time using prineo).We check our patients frequently after an abdominoplasty at 1 week, 2 weeks, 3 weeks, 6 weeks, 3 months, 6 months, 1 year.They have drains initially, which remain until the drainage is very minimal on each side ie ( less than 10 mis ), then they wear compression tights and a binder for at least 6 weeks post operatively.After prineo is removed, the patients use 1 brown micropore tape along the length of the scar until 12 week post op.We have not changed anything in our surgical technique, application of prineo dressing, or post op management during this time, so that is why i contacted you as we were unsure of why these incidents occurred all round the same time.In the past 6 weeks however we have not had any further incidents at all.To avoid pressure though, we have started leaving a little gap at the centre of the abdominal suture line to avoid pressure there.We will watch closely for any further issues.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? please describe how was the adhesive was applied.What prep was used prior to, during or after prineo use? 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.Does the patient use or 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? no product is 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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