Model Number CLR222 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Date 12/21/2021 |
Event Type
Injury
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Event Description
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It was reported a patient underwent a total knee replacement (b)(6) 2021 and topical skin adhesive was used.Severe allergic reaction to the patient after usage of adhesive on the suture line.Additional information has been requested.
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Manufacturer Narrative
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(b)(4).Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.Are any photos available of the reaction? yes pfa.Please describe how was the adhesive was applied.Was used as per recommendation.What prep was used prior to, during or after adhesive use? sterilium was used to clean the site before application and then nothing was applied normal gauze dressing was used.Was a dressing placed over the incision? yes.If so, what type of cover dressing used? normal gauze dressing.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? (not aware of).Is the patient hypersensitive to pressure sensitive adhesives? no.Were any patch or sensitivity tests performed? no.Patient demographics: initials / id, gender, age or date of birth; bmi : rw, female , 60yrs of age.Patient pre-existing medical conditions (ie.Allergies, history of reactions) no.Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? no.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? current patient status.No current status after antiallergic medication allergic reaction was reduced.No product available for analysis.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Note: events reported on mw# 2210968-2022-00776.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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Manufacturer Narrative
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Product complaint # (b)(4).Additional information: post surgery the patient had developed severe skin allergy (not infection as told by the doctor) redness on the skin post surgery in 10-12 days post application.Bilateral tkr.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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Manufacturer Narrative
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Product complaint # (b)(4).Additional information has been requested however and obtained.If further details are received at a later date a supplemental medwatch will be sent.Are any photos available of the reaction? yes pfa.2) please describe how was the adhesive was applied.Was used as per recommendation.3) what prep was used prior to, during or after adhesive use? sterilium was used to clean the site before application and then nothing was applied normal gauze dressing was used.4) was a dressing placed over the incision? yes.5)if so, what type of cover dressing used? normal gauze dressing.6)is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? (not aware of).7)is the patient hypersensitive to pressure sensitive adhesives? no.8)were any patch or sensitivity tests performed? no.9)patient demographics: initials / id, gender, age or date of birth; bmi : rw, 60yrs of age.10)patient pre-existing medical conditions (ie.Allergies, history of reactions) no.11)has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? no.12)was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? current patient status.No current status after antiallergic medication allergic reaction was reduced.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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