Model Number CLR222US |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Skin Discoloration (2074); Skin Inflammation/ Irritation (4545)
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Event Type
Injury
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Event Description
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It was reported a patient underwent cesarean section surgery on an unknown date and topical skin adhesive was used.Reddening occurred.Steroid was used and now the skin is darker but not a problem.The symptoms of redness disappeared, but a mark remained.Further details are not provided.No sample will be returned.Additional information has been requested.
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Manufacturer Narrative
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(b)(4).Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Is photo available of patient reaction? what date /day post op was the reaction noted? was prescription strength medication treatment provided? was any surgical intervention performed? please describe how was the adhesive was applied.What prep was used prior to, during or after adhesive 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? was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? patient demographics: initials / id, gender, age or date of birth; bmi? patient pre-existing medical conditions (ie.Allergies, history of reactions)? has the patient used or been 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? current patient status.No product is available for return.
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Manufacturer Narrative
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Product complaint # (b)(4).Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.Is photo available of patient reaction? no photo is available.What date /day post op was the reaction noted? unknown.Was prescription strength medication treatment provided? unknown.Was any surgical intervention performed? unknown.Please describe how was the adhesive was applied.Unknown.What prep was used prior to, during or after adhesive use? unknown.Was a dressing placed over the incision? if so, what type of cover dressing used?unknown.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde?unknown.Is the patient hypersensitive to pressure sensitive adhesives? unknown.Was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? unknown.Patient demographics: initials / id, gender, age or date of birth; bmi unknown.Patient pre-existing medical conditions (ie.Allergies, history of reactions) unknown.Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? unknown.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown.Current patient status.Steroid was used and the sympton disappeared.The dark mark left on the skin but not a problem." 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, or its employees that the report constitutes an admission that the product, ethicon, 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.
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Search Alerts/Recalls
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