MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES; DRESSING, WOUND, OCCLUSIVE

Model Number 4901730021913

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

Patient Problems Purulent Discharge (1812); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/28/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6); device was used for treatment, not diagnosis.Patient information was not provided for reporting.This report is for (band aid brand (b)(6) large 6ct ap (b)(4)).Device is not distributed in the united states, but is similar to device marketed in the usa (band aid brand (b)(6) bandages all purpose 1ct usa (b)(4), usa).Udi #: (b)(4), upc #: (b)(4), expiration date: ni.Lot #: ni.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.(b)(4).Refer to consumer alleged about misuse/off-label use and the burn wound also felt like it had expanded.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A consumer reported an event with band aid brand ((b)(6)) bandages.On (b)(6) 2021, a consumer touched the bottom of a pan and got burned and red.He/she scratched the burn while sleeping on the same day and it became a wound, so on the following day (b)(6)2021, he/she applied band aid brand ((b)(6)) large 6ct ap (b)(4).On the following day (b)(6) 2021, he/she was surprised to see a huge amount of exudate coming out when he/she removed the strip because it was greatly swollen white.The burn wound also felt like it had expanded, but he/she flushed it with tap water and replaced the product with a new one.On (b)(6) 2021, he/she visited the hospital.The exudate was light yellow, but he/she was told that it was not suppurative.At the time of this reporting, he/she was being treated with the prescribed (unspecified) ointment.Additional details could not be obtained.

• Brand Name: BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview road; skillman NJ
• Manufacturer (Section G): COLOPLAST; coloplast hungary kft.; h-4300 nyirbator; coloplast u.2 ; HU
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 13019442
• MDR Text Key: 286926175
• Report Number: 2214133-2021-00052
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 4901730021913
• UDI-Public: (01)4901730021913(10)NI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4901730021913
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention