MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE; SURGICAL SEALANT

Catalog Number CLR222

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rash (2033); Skin Irritation (2076)

Event Date 11/08/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Attempts to obtain the following information have been made with no response to date.If further details are received at a later date a supplemental medwatch will be sent.What other type of medical / surgical treatment was provided to treat the reaction? what prep was used prior to, during or after prineo use? how many layers of adhesive were used over during application? was a dressing placed over the incision? if so, what type of cover dressing used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? what is the physicians opinion of the contributing factors to the reaction? 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? current status of patient? related adverse events captured in reports: 2210968-2019-90743.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.

Event Description

It was reported a patient underwent a bilateral anterior & lateral compartment fasciotomies on (b)(6) 2019 and topical skin adhesive was used.2 weeks post op, reaction appeared.Patient removed dressing at home with warm water in the shower.Reporting a red rash under and around the edges of the adhesive.Prior to this patient reports no issues.Visited general practioner two days later as saw no improvement.General practioner commenced oral and topical steroids.Reaction improved.Oral steroids finished after 5 days.Patient continued on topical treatment.However no further improvement in wound area was reported, milder rash persisted.(b)(6) 2019 a new rash appeared on the patients thighs, progressing to 'welts' (b)(6) 2019.Pt still using topical steroid cream.Oral steroids started again on (b)(6) 2019 post ortho clinic visit.Clinic have recommended pt cease topical over this weekend to determine if unintentional steroid exposure to the thighs is causing the rash and welts.Patient booked to revisit clinic (b)(6) 2019 for follow-up review.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 1/8/2020.The following additional information was requested and obtained: what prep was used prior to, during or after prineo use? chlorhexidine prep pre-op only.How many layers of adhesive were used over during application? one layer.Was a dressing placed over the incision? if so, what type of cover dressing used? just prineo.What is the physicians opinion of the contributing factors to the reaction? patient strong allergic history & potentially reaction to topic steroid cream itself.¿ was the patient exposed to similar products, such as artificial nails? history of allergy to bandaids.¿ was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? no known prior exposure.¿ current status of patient at revisit on (b)(6) ? wound healing well.Reaction resolved within several days once topical steroid was stopped (as well as prineo removed).

• Brand Name: DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9449721
• MDR Text Key: 170932598
• Report Number: 2210968-2019-90742
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031237339
• UDI-Public: 10705031237339
• Combination Product (y/n): N
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

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
• Device Catalogue Number: CLR222
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 01/08/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR