MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT; SURGICAL SEALANT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Itching Sensation (1943); Local Reaction (2035)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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# 2210968-2021-06979, mw# 2210968-2021-06980, 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.

Event Description

It was reported in a journal article 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.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12273349
• MDR Text Key: 264945379
• Report Number: 2210968-2021-06978
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR