Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Itching Sensation (1943); Local Reaction (2035)
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Event Date 01/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Additional information was requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that ethicon products (dermabond prineo, vicryl suture) involved caused and/or contributed to the post-operative complications described in the article? dermatitis, itching, infection, erythemato-edematous and vesicular.Lesion does the surgeon believe there was any deficiency with the ethicon products (dermabond prineo, vicryl suture) used in these procedures? were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Citation: medicine (2021); 100 (20): e26053.Doi: http://dx.Doi.Org/10.1097/md.0000000000026053.Note: events reported on mw# 2210968-2021-06976, mw# 2210968-2021-06977, mw# 2210968-2021-06978, mw# 2210968-2021-06979, mw# 2210968-2021-06981, mw# 2210968-2021-06982, mw# 2210968-2021-06983.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 in a journal article title: title: postoperative contact dermatitis caused by skin adhesives used in orthopedic surgery incidence, characteristics, and difference from surgical site infection authors: sang pil so, md, jae youn yoon, md, ji wan kim, md, phd citation: medicine (2021); 100 (20): e26053.Doi: http://dx.Doi.Org/10.1097/md.0000000000026053.The aim of this retrospective study is to evaluate the incidence, characteristics, and treatment outcomes of contact dermatitis caused by using skin adhesives and differentiate it from ssi.Between march 2018 to june 2020, a total of 143 patients (59 male and 84 female; mean age of 60.8 years) whose surgical wound was closed using a liquid skin adhesive (dermabond prineo, skin closure system, ethicon) were included in the study.When using the skin adhesive during surgery, the subcutaneous layer was sutured using vicryl sutures (ethicon).Reported complications included: a (b)(6)-year-old female patient had a contact dermatitis with a manifestation of an itchy eczematous lesion around the surgical wound and was treated with local steroid ointment without additional antibiotics.Also, the mesh applied at the surgical wound was removed immediately.The skin lesion resolved after 1 week of treatment.A (b)(6)-year-old male patient had skin infection and contact dermatitis with manifestation of an itchy erythemato-edematous vesicular lesion around his surgical wound on the fourth postoperative week and was prescribed with oral antibiotics for 3 days and a local steroid ointment.The patient¿s pruritis resolved 2 weeks later and the skin lesions resolved after 4 weeks of treatment.A (b)(6)-year-old female patient had contact dermatitis with manifestation of an itchy erythemato-eczematous and papulovesicular lesion around her surgical wound on the fourth postoperative week.After treatment with an antihistamine and local steroid ointment, the skin lesions resolved completely.A (b)(6)-year-old female patient had contact dermatitis with manifestation of an erythemato-edematous and vesicular lesion around her surgical wound on the sixth postoperative week.The mesh over her surgical wound had not been removed, and it was removed immediately.Local steroid ointment application and oral antihistamines were prescribed, and the patient was cured after 6 weeks of treatment.In conclusion, the surgical wound healed in all cases where a skin adhesive was used.However, contact dermatitis occurred in 2.8% of our patients.Therefore, clinicians should be aware of the risk of skin adhesive-related contact dermatitis and monitor the surgical wound regularly in cases where they are used.
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Search Alerts/Recalls
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