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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erythema (1840); Discharge (2225); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? (b)(6) year old male, (b)(6) year old female, (b)(6) year old male.If yes, please provide a complaint reference numbers.Does the surgeon believe that ethicon products / prineo, involved caused and/or contributed to the adverse events described in the article, specifically: reaction, dermatitis, blisters, erythema, daily dry dressing changes, oral keflex, topical corticosteroid cream? if yes, provide details of event and specific suture product code.Can specific patient demographics be provided for each of the subjects of this article? if yes, please include: date of procedure, where procedure was performed, specific medical/surgical intervention per patient, product involved, pre-existing conditions.Are the product code and lot numbers available for devices used, prineo? (b)(4).

Event Description

It was reported in a manuscript draft that a case series of 3 patients who developed allergic contact dermatitis to prineo after a primary total knee arthroplasty.Three patients presented on average 8 days (range 5-10 days) for their first post-operative follow-up with complaint of dermatological issue.All three patients had undergone skin closure with topical skin adhesive.On physical exam, the first patient ((b)(6)-year old male) had mild erythema at the incision site.The topical skin adhesive dressing was immediately removed and he was started on keflex.When he returned a week later, he had progressed to numerous erythematous papules and 1-2 mm vesicles.He was referred for dermatological consultation and diagnosed with allergic contact dermatitis.He was started on a topical corticosteroid cream and had complete resolution of his symptoms in 4 weeks.The second patient ((b)(6)-year old female) presented for her first post-operative visit 10 days after surgery.Her visiting home nurse noted blistering and drainage of her surgical site on post-operative day 4.She was given a 10-day course of keflex and advised to perform daily dry dressing changes.At 3 months, she had complete resolution of her blistering.The third patient ((b)(6)-year old male) presented with well-defined erythematous scaly and crusted plaque on the anterior aspect of the knee surrounding the incision.The topical skin adhesive dressing was removed and the patient was started on keflex.He was referred to dermatology where he was started on topical corticosteroid cream.His symptoms improved after 2 weeks.At one year follow-up, no reoccurrence occurred and no episodes of superficial or deep joint infection occurred in the three patients.Additional information was requested.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6745985
• MDR Text Key: 81115835
• Report Number: 2210968-2017-33145
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• 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?: No
• Date Manufacturer Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention