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); Unspecified Infection (1930); Itching Sensation (1943); Rash (2033)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4). (b)(4). 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. 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. Does the surgeon believe that ethicon product (prineo) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon product (prineo) used in this procedure? was the patient discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Citation: doi: https://doi. Org/10. 3928/01477447-20200827-01.

Event Description

It was reported via a journal article: title: allergic contact dermatitis to dermabond prineo after elective orthopedic surgery authors: bernadette m. Ricciardo, facd; rosemary l. Nixon, facd; mei mui tam, facd; ross r. Radic, fracs (orth); brendan j. Ricciardo, fracs (orth) citation: doi: https://doi. Org/10. 3928/01477447-20200827-01. The dermabond prineo skin closure system (ethicon) is a wound closure device that combines a 2-octyl cyanoacrylate liquid adhesive and a self-adhesive polyester mesh. Although cyanoacrylates traditionally have been associated with low rates of sensitization, allergic contact dermatitis (acd) to dermabond products is being increasingly reported after orthopedic surgery. The authors describe the first case series of acd to dermabond prineo skin closure system (ethicon) where patch testing confirmed the diagnosis in all patients. Reported complications included allergic contact dermatitis in 6 patients, of which, 5 patients had itching within 4 days of surgery and rash within 5 days. All 5 of these patients reported previous exposure to dermabond products. All patients had removal of the adhesive and mesh earlier than planned and were treated with corticosteroids. In addition, 4 patients received systemic antibiotics; however, only 1 had a microbiologically confirmed superficial skin infection. In all patients, the dermatitis resolved within 2 weeks of dressing removal, with no adverse effect on the orthopedic outcome. Patch testing showed positive reactions to dermabond prineo glue for all patients. Orthopedic surgeons should be aware of the potential for acd to dermabond prineo skin closure system (ethicon), especially among patients with previous exposure to dermabond products. The authors discuss the risk factors for acd to dermabond prineo in the orthopedic cohort and provide recommendations for prevention and management.

• 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; san lorenzo 00754
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10632315
• MDR Text Key: 213023819
• Report Number: 2210968-2020-07666
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• 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?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/12/2020
• 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?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/05/2020 Patient Sequence Number: 1