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

Model Number 4901730021906

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

Patient Problems Fungal Infection (2419); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/16/2022

Event Type  Injury  

Event Description

A female consumer reported that she saw a dermatologist because the skin of her hands peeled off because of use of a detergent.The affected area was treated with a mixed medicine of betamethasone ointment and heparinoid oil-based cream for a week.However, the area did not improve.The consumer applied band aid brand kizu power pad (kpp) regular to the area on dermatologist's instructions to change the mixed medicine to kpp.After that, the affected area got moldy caused by candida.She applied kpp three times in 10 days.She then saw the dermatologist again and was told that there was a possibility that the consumer apos's way of applying kpp was not good.However, after candida was detected, the dermatologist stated that he/she failed to treat the affected area.Consumer stopped using kpp and a medicine for treatment of candidiasis was prescribed.The patient is still experiencing symptoms.This is 1 of 3 med-watches being submitted as three devices were involved in this event.See medwatches 2214133-2022-00042 & 2214133-2022-00043.The same patient is represented in each medwatch.

Manufacturer Narrative

Johnson & johnson consumer, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which johnson & johnson consumer, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, johnson & johnson consumer, inc.Or its employees that the report constitutes and admission that the device, johnson & johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.Patient identifier, weight, and ethnicity and race were not provided for reporting.This report is for (band aid brand kizu power pad (kpp) regular 10ct ap (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 381371175338 8137117533usa 8137117533usa).Udi #(b)(4).Upc #: (b)(4).Lot number: 3011c.Expiration date: aug-31-2024.Device is not expected to be returned for manufacturer review/investigation.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The product was manufactured on september 13, 2021.(b)(4).This is 1 of 3 med-watches being submitted as three devices were involved in this event.See medwatches 2214133-2022-00042 & 2214133-2022-00043.The same patient is represented in each medwatch.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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 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: 15392229
• MDR Text Key: 299581645
• Report Number: 2214133-2022-00041
• Device Sequence Number: 1
• Product Code: NAD
• 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: 08/17/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 4901730021906
• Device Lot Number: 3011C
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female