Model Number CLR222US |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Erythema (1840); Hypersensitivity/Allergic reaction (1907)
|
Event Date 05/29/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint # (b)(4).(b)(4).The following information was requested, however not received.To date the device has not been returned.If further details are received at a later date a supplemental medwatch will be sent.A photo was mentioned to be available, please provide.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: age or date of birth; bmi? patient pre-existing medical conditions (ie.Allergies, history of reactions)? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
Event Description
|
It was reported a patient underwent a magec growing rod revision on (b)(6) 2020 and surgical sealant was used.On (b)(6) 2020 patient had ertythema and wheals to peri-incision region; spread to bilateral flanks and thighs.Treatment administered mometasone ointment two times daily, mupirocin on top of steroid cream bid, then also to incision itself two times daily once adhesive is removed, zyrtec in am, benadryl in pm, eventually prescribed steroid dosepak when topical agents did not resolve reaction.The incision healing at this time.Lot number is unknown.Additional information has been requested.
|
|
Manufacturer Narrative
|
Product complaint#: (b)(4).Date sent to the fda: 8/12/2020.The following information was requested and obtained.If the further details are received at a later date a supplemental medwatch will be sent.Please describe how was the adhesive was applied as per standard dermabond prineo guidelines what prep was used prior to, during or after prineo use? duraprep prior to surgery was a dressing placed over the incision? if so, what type of cover dressing used? yes, mepilex ag post op is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no.Is the patient hypersensitive to pressure sensitive adhesives? no.Were any patch or sensitivity tests performed? no.Patient demographics: age or date of birth; bmi; 13 yrs., bmi 32.8.Patient pre-existing medical conditions (i.E.Allergies, history of reactions).No prior allergies.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.
|
|
Search Alerts/Recalls
|
|