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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Itching Sensation (1943); Rash (2033); Skin Irritation (2076); Tissue Damage (2104); Reaction (2414); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form. 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? if yes, please provide a complaint reference number. Can specific patient demographics be provided for each of the subjects of this article? if yes, please include: initial procedure date, procedure name, specific medical/surgical intervention per patient, specific product code and lot number involved with each patient , patient pre-existing medical conditions (ie. Allergies, history of reactions), was the patient exposed to similar products, such as artificial nails. Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? reference journal article: http://www. Sciencedirect. Com/science/article/pii/s0883540317305958?via%3dihub.

Event Description

It was reported in a journal article that the patient underwent an elective orthopedic surgery on an unknown date between 2013 to 2016 and topical skin adhesive was used. The patient experienced an allergic contact dermatitis to the topical skin adhesive. The patient possibly developed mild/moderate/severe reaction. The patient underwent careful removal of the prineo skin adhesive and underwent dressing changes daily and treated two times daily with a layer of 0. 05 clobetasol cream and 2 layers of vanicream and covered with a towel soaked in water and white vinegar. It was possible that the patient was treated with oral antihistamines/topical steroids/oral corticosteroids/ intravenous or oral antibiotics and was possibly referred to dermatology due to suspicion of potential cellulitis. It was possible that the patient was evaluated for prosthetic joint infection with inflammatory markers and possibly underwent a total knee arthroplasty joint arthrocentesis to evaluate for infection. It was also possible that the developed a subcutaneous fluid collection at the incision site at 6 weeks postoperatively and underwent reoperation for irrigation, debridement, and primary closure which was potentially related to the allergic contact dermatitis. All symptoms resolved at a mean of 22 days. Additional information has been 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 08876 0151
• Manufacturer (Section G): ETHICON INC. SAN LORENZO; road 183, km. 8.3; san lorenzo PR 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7034861
• MDR Text Key: 92160030
• Report Number: 2210968-2017-71252
• 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

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/15/2017 Patient Sequence Number: 1