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.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 10/20/2020.The following information has been requested and the following was received.To date the device has not been received.If the 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.The cases were reported to the regional accounts manager for ethicon here in perth, australia.I am not aware of the complaint reference number(s).Does the surgeon believe that ethicon products involved /prineo caused and/or contributed to the post-operative complications described in the article? the surgeons involved do believe the prineo glue caused the allergic contact dermatitis that developed post-operatively in these patients.Does the surgeon believe there was any deficiency with the ethicon products/prineo used in this procedure? the surgeons involved do not believe there is any deficiency in the ethicon products, however they do acknowledge allergic contact dermatitis to be a potential adverse effect of this skin closure technique.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• 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
• 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
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 10/12/2020
• Supplement Dates FDA Received: 10/20/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention