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

Catalog Number CLR222US

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hypersensitivity/Allergic reaction (1907); Tissue Damage (2104); No Code Available (3191)

Event Date 04/16/2018

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.The actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch mah922 , batch lmr875 , batch leh041 additional information was requested and the following was obtained: what is the procedure name and initial procedure date? knee arthroplasty; date : (b)(6) 2018.How was the prineo applied on the mesh? apply as video recommendation.What prep was used prior to product application? normal saline.What was the location and incision size of the application? at knee skin around 12 cm.Was a dressing placed over the incision? if so, what type of cover dressing used? they cover prineo at 1st layer, 2nd layer is sterile gauze pads and curafix® during first 3 days at the hospital.After 3 days, doctor peel curafix and gauze away and replace with tegaderm with pad.(day 4 ¿ patient back home).What date did the reaction occur on? day 5, post op , occur at home.What does the reaction look like and how large of an area does the reaction cover? was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.Treat with antibiotics; no steriods; after skin reaction, blister breaks, wash the area with soap and water, then apply a bandage.Can you identify the lot number of the product that was used? possible batch : mah922 , lmr875 , leh041 is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no.If the patient is female were they exposed to similar products, such as artificial nails? patient is male, (b)(6).What is the most current patient status? see photos.Patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions) (b)(6).Was prineo or skin adhesive used on the patient in a previous surgery or wound closure? no.

Event Description

It was reported that a patient underwent a knee arthroplasty procedure on (b)(6) 2018 and topical skin adhesive was used.After using the topical skin adhesive on the patients skin for 2-3 days, the patient experienced a severe allergic reaction.The patient was treated with antibiotics.After the skin reaction, the blister breaks, and the area was washed with soap and water, then a bandage was applied.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 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7505603
• MDR Text Key: 107960253
• Report Number: 2210968-2018-72722
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• 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: 04/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR