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 Hypersensitivity/Allergic reaction (1907); Local Reaction (2035)

Event Date 03/26/2016

Event Type  Injury  

Manufacturer Narrative

Product complaint (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.Was the case discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products involved: dermabond prineo caused and/or contributed to the post-operative complications (skin reaction (dermatitis) and medication required) described in the article? does the surgeon believe there was any deficiency with the ethicon products: dermabond prineo used in this procedure? 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.No product will be returned.Citation: dermatitis, vol 27, number 2, march/april 2016, 75-76; doi: 10.1097/der.0000000000000163.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Title: severe allergic contact dermatitis to dermabond prineo, a topical skin adhesive of 2-octyl cyanoacrylate increasingly used in surgeries to close wounds.Authors: mark d.P.Davis, md; michael j.Stuart, md.Citation: dermatitis, vol 27, number 2, march/april 2016, 75-76; doi: 10.1097/der.0000000000000163.This study reports a case of allergic contact dermatitis to a topical skin adhesive of 2-octyl cyanoacrylate.A (b)(6)-year-old white woman presented with severe acute dermatitis involving and surrounding the surgical wound from her left knee arthroplasty performed 3 days prior.The wound had been closed with the topical adhesive dermabond prineo skin closure system (ethicon).She reported a similar, milder rash a year previously after a similar closure of a right knee arthroplasty.The patient had extensive patch testing standard, plastics, and glue series, as well as her own products and those used during her operation (dermabond prineo liquid form (ethicon), dermabond prineo mesh (ethicon), and chloraprep 1-step with tint, a competitors product that had been used to cleanse the area.At the final patch test reading, the patient was noted to have an extreme patch test reaction to dermabond prineo liquid adhesive (ethicon).Topical corticosteroids were prescribed.The dermatitis responded gradually to the topical corticosteroid therapy (clobetasol cream and wet dressings) over 4 weeks.The response of allergic contact dermatitis to topical corticosteroids over 3 to 4 weeks shows that the reaction is to the liquid form of acrylates.Thus, it was not necessary to remove the dermabond prineo (ethicon) after the operation.Once cured (polymers), the acrylates are much less likely to cause allergic contact dermatitis.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11554405
• MDR Text Key: 241851950
• Report Number: 2210968-2021-02630
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• 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: 02/26/2021
• 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: 72 YR