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Catalog Number DNX12 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Hypersensitivity/Allergic reaction (1907); Rash (2033)
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Event Date 11/13/2023 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned additional information has been requested and received.¿ what is the procedure name? laparoscopic hiatal hernia repair ¿ what is the procedure date? 11/10/2023 ¿ what date did the reaction occur on? 11/13/2023 ¿ what does the reaction look like and how large of an area does the reaction cover? topical dermatitis which appears to have initiates from the incisions sites and spread the patient¿s abdomen ¿ do you have any pictures of the reaction? yes.It is on the patient portal message ¿ was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.Patient was initially prescribe abx, but was discontinued and recommended to apply otc hydrocortisone cream ¿ is the device available to be returned for evaluation? if yes, to who and where can a return kit be send for recollection? no ¿ what is the most current patient status? rash is improving ¿ was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? yes additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Were any cultures taken? results? 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: 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)? what is the physician¿s opinion as to the etiology of or contributing factors to this event? no product available for return.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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Event Description
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It was reported a patient underwent a laparoscopic hiatal hernia repair on (b)(6) 2023 and topical skin adhesive was used.Patient had reaction to either the prep versus adhesive causing a horrible macular papular vesicular rash.Has topical dermatitis which appears to have initiated from the incisions sites and spread the patient¿s abdomen.Patient treated, was initially prescribe antibiotics, but was discontinued and recommended to apply otc hydrocortisone cream.Issue has improved.Additional information has been requested.
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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.Were any cultures taken? results? 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: 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)? what is the physician¿s opinion as to the etiology of or contributing factors to this event? response: i do not think investing more time to answer the rest of your questions is helpful or useful to conclude this investigation.We saw an uptick in allergic reactions to the glue that was being used over our surgical sites which we do believe was caused by the dermabond (the prep was not changed/it was many different procedures and surgeons/no formaldehyde allergies).We have seen less complaints from patients in this regard over the last month, likely do to depleting the batch being used.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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