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

Catalog Number CLR222US

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Skin Irritation (2076); No Code Available (3191)

Event Date 06/27/2018

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.Additional information was requested and the following was obtained: how was the device applied to the incision ¿ proximal to distal, uses 2 prineo and overlap by ½¿ ¿ second one is used because of the hyperflexing; no tension; lets dry, wraps knee what prep was used prior to product application? unknown.What was the location and incision size of the application? was a dressing placed over the incision? if so, what type of cover dressing used? sometimes 2 x 4.Please explain how the skin layers were closed to reduce skin tension? capsule is closed with interrupted 1-0, 2-0 vicryl suture; skin 3-0 monocryl to close dermis.Can you identify the lot number of the product that was used? unknown.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown.What is the most current patient status? patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions) : unknown - full spectrum of patients.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown.

Event Description

It was reported that a patient underwent a total knee procedure on an unknown date and topical skin adhesive was used.The topical skin adhesive was applied to the skin on knee if full flexion.Approximately two weeks post op, the patient had a bad reaction to the device including blistering and pain.The blisters had popped and dried.The patient may have been treated with oral antibiotics or topical antibiotic ointment.The patient had no reaction when a like device was used on the other knee in a previous procedure.Patient may have been treated with topical skin ointment for the reaction.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: 7684502
• MDR Text Key: 113870569
• Report Number: 2210968-2018-74327
• 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: 06/27/2018

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: CLR222US
• Date Manufacturer Received: 06/27/2018
• 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