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

Catalog Number CLR222

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Skin Irritation (2076); 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.Additional information was requested and the following was obtained: what is the initial procedure date if known? - unknown.How was the prineo applied? ¿ surgeon advised as per instructions and normal technique.What prep was used prior to product application? - unknown.What was the location and incision size of the application? - knee.Was a dressing placed over the incision? if so, what type of cover dressing used? - unknown.What date did the reaction occur on? - unknown.What does the reaction look like and how large of an area does the reaction cover? ¿ the surgeon showed me a photo, and the reaction seemed to be in the same shape as prineo 22.Do you have any pictures of the reaction? seen, but not supplied by surgeon.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.Product removed and treated by local gp with corticosteroid cream.Can you identify the lot number of the product that was used? no.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unaware.If the patient is female, were they exposed to similar products, such as artificial nails? unaware.What is the most current patient status? - fine.Patient demographics: age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions) - unknown.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? yes.

Event Description

It was reported that a patient underwent a total knee replacement procedure on an unknown date and topical skin adhesive was used.It was reported that the topical skin adhesive caused a reaction.The topical skin adhesive was removed and the patient was treated by local gp with corticosteroid cream.The patient had previous unrelated procedure some time ago and topical skin adhesive was used without any issue.Additional information was requested.

• Brand Name: DERMABOND PRINEO 22CM
• 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; 982 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: 7687533
• MDR Text Key: 114009045
• Report Number: 2210968-2018-74353
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031237339
• UDI-Public: 10705031237339
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: CLR222
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2018
• 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