MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE; SURGICAL SEALANT

Catalog Number CLR222US

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Skin Irritation (2076)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Additional information was requested and the following was obtained: what is the name and date of the surgical procedure? tka.What type of skin prep was used? chloroprep.Was incision re-prepped before closure? if so, with what? if so, was the prep allowed to dry? yes.Location and incision size of prineo application? knee.Less than 8.6 inches.Was a dressing placed over the incision? if so, what type of cover dressing used? mepilex dressing.When did the reaction first occur (event date)? date reported.What does the reaction look like? see pictures.Are any pictures available? yes.How large of an area does the reaction cover? see pictures.Has the patient received any medical or surgical intervention as a result of the event (other than the steroid ointment)? please provide details."benedryl" over counter; keflex.Did the patient have prineo applied at any other site? if so, where and is there any sign of reaction at that site? no.Is this the first time the patient ever used dermabond prineo? yes.Were any patch or sensitivity tests performed? no.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? don¿t know.How is the patient today? don¿t know.Is the product involved in the event or a representative sample (product from the same lot number) available for evaluation? no.

Event Description

It was reported that a (b)(6) male patient underwent a total knee arthroplasty procedure on an unknown date and topical skin adhesive was used.Eleven days post op the patient had a skin reaction to the topical skin adhesive.The patient was treated with "benedryl" over the counter and keflex.Additional information has been requested.

• Brand Name: DERMABOND PRINEO 22CM SKIN CLOSURE
• 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; road 183, km. 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8143009
• MDR Text Key: 129650043
• Report Number: 2210968-2018-77587
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133864
• 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: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR