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 Problems Fluid Discharge (2686); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

A consumer of unknown gender or age used a band aid brand kizu power pad for protection for an abrasion and due to body fluid leaking from the scratch.The consumer went to the hospital and was told by the physician to refrain from using the product and apply an anti-suppurative medication which was prescribed by a physician and was told to refrain from using the product for the time being.The consumer complied and stopped using the product for half a month.Consumer stated they applied anti-suppurative medication and a gauze that they purchased at a drug store at consumers own discretion.As of this reporting, the consumer was concerned they had used a gauze product.The consumer stated they went to see the physician two days later for their chronic illness with dizziness.Consumer stated time had passed, and they started using the product again.Consumer applied the product instead of a gauze.As the consumer was told by the physician, they need not apply anything to it, the consumer thought it was a shallow wound and they would consider stopping using the product.No further information was reported about this event.

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.A1, a2, a3, a4, a5: patient identifier, patient age, gender, weight, and ethnicity and race were not provided for reporting.D1, d2, d3 d4: 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 381371175338 8137117533usa 8137117533usa).Lot number-ni.D4: udi, upc, lot number and expiration date are not available.D9: device is not expected to be returned for manufacturer review/investigation h3, h4, h6: 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.H6: health effect clinical code: e2315 also refers to consumer alleged about "discharge".E2402 refers to consumer "intentional misuse/off-label use" of the product 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 HUNGARY KFT.; h-4300 hyirbator; coloplast u.2 ; HU
• Manufacturer Contact: michael connaughton ; 199 grandview rd; skillman, NJ 08558-9418 ; 9086555919
• MDR Report Key: 19115696
• MDR Text Key: 340340257
• Report Number: 2214133-2024-00017
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• 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
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention