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

Model Number 4901730021906

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

Patient Problems Itching Sensation (1943); Skin Discoloration (2074); Eczema (4547)

Event Date 07/05/2021

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient identifier, age at time of event, gender, weight, and ethnicity and race were not provided for reporting.This report is for (band aid brand kizu power pad regular ap 4901730021906 0037131785apa).Device is not distributed in the united states, but is similar to device marketed in the usa (band aid brand hydroseal bandages all purpose 1ct usa 381371175338 8137117533usa).Udi - (b)(4).Upc - 4901730021906.Lot number and expiration date - ni.Device is not expected to be returned for manufacturer review/investigation this report is for (band aid brand kizu power pad regular ap 4901730021906 0037131785apa).Device is not distributed in the united states, but is similar to device marketed in the usa (band aid brand hydroseal bandages all purpose 1ct usa 381371175338 8137117533usa).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.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 got a wound on the back of hand and applied band-aid brand kizu power pad (kpp).When the consumer removed the kpp on (b)(6) 2021, white itchy eczema appeared on the application site.The consumer stopped using the product.The consumer's symptoms did not improve after stopping use of the product and was still experiencing the symptoms while reporting this event.The consumer visited hospital for treatment.No further information regarding patient information was provided.

• Brand Name: BAND AID BRAND KIZU POWER PAD
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• 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: 12177644
• MDR Text Key: 261836236
• Report Number: 2214133-2021-00027
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 4901730021906
• UDI-Public: (01)4901730021906(10)NI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4901730021906
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 07/06/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention