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

Catalog Number CLR222

Device Problem Insufficient Information (3190)

Patient Problem Rash (2033)

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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Number of devices used on the patient? photo does not match the event description.Please send additional photo.Please describe how was the adhesive applied on the tape.What prep was used prior to, during or after prineo use? was a dressing placed over the incision? if so, what type of cover dressing used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? do you have the lot number involved.What is the physicians opinion of the contributing factors to the rash? what is the most current patient status? is the product or representative sample (product from the same lot number) available for evaluation? patient demographics: initials / id; age or date of birth; bmi ; gender.Patient pre-existing medical conditions (ie.Allergies, history of reactions).For female patients ask: was the patient exposed to similar products, such as artificial nails.Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure?.

Event Description

The patient underwent a total knee replacement procedure on (b)(6) 2018 and topical skin adhesive was used.The patient presented back to the doctor on (b)(6) 2018 with red rash over the knee incision sites.The patient was treated with two rounds of steroids and anti-histamine medication which has since cleared up the red rash.Additional information has been requested.

Manufacturer Narrative

Product complaint (b(4).Date sent to fda: 6/12/2018.Additional information was requested and the following was obtained: the case was a total knee replacement which used a robot to help with the navigation of the prosthesis.The incision in the photo is the pin site in the shin used for navigation arrays from the robot.No further information is available.

• 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: 7530973
• MDR Text Key: 108855276
• Report Number: 2210968-2018-72951
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031237339
• UDI-Public: 10705031237339
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2018
• 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