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

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

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033)

Event Date 08/09/2021

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient identification, weight and ethnicity were not available for reporting.Device is not expected to be returned for manufacturer review/investigation.This report is for (band aid brand kizu power pad unspecified ap not applicable rgebabkapa rgebabkapa).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 (b)(4)).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 (b)(4)).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 reported an event with band aid brand kizu power pad (kpp).On (b)(6) 2021, a (b)(6) male consumer got scratch wounds on his arm and leg.When he consulted with a pharmacist at a drug store, he was recommended kpp.Therefore, he purchased kpp and applied it to the wound.On the next day, (b)(6) 2021, the area where kpp was applied became itchy.On (b)(6) 2021, he removed kpp because he could not stand the itching, the area where it was applied turned red and had a rash.He stopped using kpp, and when he consulted with the pharmacist, the pharmacist recommended flucort (fluocinolone acetonide).As of this reporting, he was applying flucort.The consumer is still experiencing symptoms.

• Brand Name: BAND AID BRAND KIZU POWER PAD
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC.; 199 grandview road; 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: 12375392
• MDR Text Key: 268504007
• Report Number: 2214133-2021-00036
• Device Sequence Number: 1
• Product Code: NAD
• 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: 08/16/2021

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 93 YR