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

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

Patient Problem Fungal Infection (2419)

Event Type  Injury  

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.A2: it was reported that patient age was in her 30s.Exact age or date of birth is unknown.A4, a5: patient weight, patient ethnicity and race were not provided.D1, d2, d3, d4: this report is for band aid brand kizu power pad unspecified ap.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 usa 381371175338).Lot number was not available for reporting.Udi is not available for reporting.D9: device is not expected to be returned for manufacturer review/investigation h3, h4, h6: device evaluation 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.H6: health effect clinical code-e1902 also refers to consumer alleged about " mold grew in pores".This event is being reported as an overabundance of caution.Following product use consumer reported molds grew in the pores.Product was applied on the finger and consumer developed bumps on the side of finger.Dermatologist was consulted who confirmed that mold grew in the pores.No report of any significant medical treatment or intervention.Based on available information, event interpreted as mold infection at application site and coded to fungal infection.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A female consumer, in her 30s, reported an event regarding unspecified band aid brand kizu power pad (hydro seal bandage).Around the spring of 2023, while she was using the product on her finger, about 3 days after she applied it, bumps appeared on the side of the finger.When she visited a dermatologist, she was told that mold grew in the pores, so she stopped using the product.At the time of the reporting, the skin of the area had returned to normal and there was no problem.The symptoms improved after the patient stopped using the product.

• 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 avenue; skillman NJ 08558 9418
• Manufacturer (Section G): COLOPLAST; coloplast hungary kft.; h-4300 nyirbator; coloplast u.2 ; HU
• Manufacturer Contact: michael connaughton ; 199 grandview rd; skillman, NJ 08558-9418 ; 9086555919
• MDR Report Key: 18708332
• MDR Text Key: 335404442
• Report Number: 2214133-2024-00008
• 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: 01/22/2024

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: 01/22/2024
• Initial Date FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female