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

Catalog Number CLR222US

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

Patient Problems Rash (2033); Skin Irritation (2076); Tissue Damage (2104)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.(b)(4).Additional information was requested and the following was obtained: what are the procedure name(s) and date(s)? total knee replacement.What does the reaction look like and how large of an area does the reaction cover? redness and blistering only under the prineo tape.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 precautionary antibiotics prescribed.What is the most current patient status? unknown at this time.Are photos available of the reaction? no photos available.Initial procedure date: no, not available.What post op date did the reaction occur? reaction occurred prior to the 2 week follow up.Please describe how was the adhesive was applied on the tape ¿ as per ifu; sales rep has reviewed technique with pa.What prep was used prior to, during or after prineo use? unknown.Was a dressing placed over the incision? if so, what type of cover dressing used? unknown.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no known allergies.Is the patient hypersensitive to pressure sensitive adhesives? unknown.Were any patch or sensitivity tests performed? unknown.Do you have the lot number involved ? unknown.What is the physicians opinion of the contributing factors to the reaction? unknown.What is the most current patient status? unknown.Patient demographics: initials / id; age or date of birth; bmi ; gender: unknown.Patient pre-existing medical conditions (ie.Allergies, history of reactions).Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown.

Event Description

It was reported a patient underwent a total knee replacement on an unknown date and topical skin adhesive was used.Patient developed a rash under the adhesive with blistering and redness postoperatively.The product was removed and precautionary antibiotics were prescribed.No device available for return.Additional information was 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 PR; 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: 8729767
• MDR Text Key: 149060424
• Report Number: 2210968-2019-83224
• 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: Physician Assistant
• Type of Report: Initial
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2019
• 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