MAUDE Adverse Event Report: ETHICON INC. DERMABOND ADVANCED 0.7ML - 6EA; ADHESIVE, TOPICAL SKIN

Model Number	DNX6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146); Skin Inflammation/ Irritation (4545)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent an unknown procedure on 4/25/2022 and topical skin adhesive was used.Adhesive was applied on the chest.Patient presented with redness over the entire chest area, receded with benadryl.Patient was still reporting pain.Heat with application, adhesive removed in recovery to try and minimize the reaction.Steroids and benadryl given, toradol for pain.No further information was provided.Additional information has been requested.

• Brand Name: DERMABOND ADVANCED 0.7ML - 6EA
• Common Device Name: ADHESIVE, TOPICAL SKIN
• 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: 14457094
• Report Number: 2210968-2022-03907
• Device Sequence Number: 14627604
• Product Code: MPN
• UDI-Device Identifier: 10705031203549
• UDI-Public: 10705031203549
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K152096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DNX6
• Device Catalogue Number: DNX6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown