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 Erythema (1840); Fluid Discharge (2686); Skin Inflammation/ Irritation (4545); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

A consumer reported an event with band aid brand kpp (kizu power pad) bandage.On (b)(6) 2022, a consumer fell while riding a motorbike and got an injury.The consumer visited a hospital and received a treatment for the fall.A doctor of the hospital instructed the consumer to apply kpp to the wound after tape applied at the hospital came off.On (b)(6) 2022, the consumer purchased kpp and started using the product.When the consumer replaced the product, yellow body fluid came out, and swelling with redness was noted around the site where the product was applied.On (b)(6) 2022, the consumer visited the hospital again and asked the doctor about the yellow liquid.The doctor stated that it was not pus but the body fluid.The doctor asked the consumer why this occurred, and the consumer stated that just applied kpp following the doctors instructions.As of this reporting, the consumer stopped using the product and ointment prescribed at the hospital was applied, and gauze was applied to guard the wound.Consumer is still experiencing symptoms.

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 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).Upc, lot number and udi# are not available.Device is not expected to be returned for manufacturer review/investigation.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.(b)(4).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: 14946896
• MDR Text Key: 295432368
• Report Number: 2214133-2022-00034
• 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: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• 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: 06/15/2022
• 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