MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE; SURGICAL SEALANT

Model Number CLR222US

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

Patient Problem Rash (2033)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported a patient underwent a pacemaker procedure on an unknown date in 2022 and topical skin adhesive was used.Patient had a rash forming on the skin where adhesive was used.Adhesive was used over the incision.Adhesive removed and treated with oral steroids.Additional information has been requested.

Manufacturer Narrative

(b)(4).Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.Please provide the following information: photo available of each patient? no, only the one.What was the procedure date? unknown.What date /day post op was the reaction noted? unknown.Please describe how was the adhesive was applied.Following the ifu: wound was approximated with hemostasis achieved.What prep was used prior to, during or after adhesive use? unknown.Was a dressing placed over the incision? if so, what type of cover dressing used? no.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown.Is the patient hypersensitive to pressure sensitive adhesives? unknown.Was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? no.Patient demographics: initials /id, gender, age or date of birth; bmi patient in image is female; others are unknown.Patient pre-existing medical conditions (ie.Allergies, history of reactions? unknown.Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? unknown.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown.Current patient status: topical steroids were used and patients recovered no product is available for return.

• Brand Name: DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14362522
• MDR Text Key: 291627043
• Report Number: 2210968-2022-03594
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLR222US
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2022
• 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