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 Purulent Discharge (1812); Erythema (1840); Scar Tissue (2060)

Event Date 04/24/2021

Event Type  Injury  

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).Udi# is not available as product is unspecified.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 381371175338 8137117533usa 8137117533usa).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 unspecified band aid brand kizu power pad (kpp).The consumer got a burn wound on the wrist with an iron and applied kpp to it.The consumer used kpp after washing the wound with water as directed, and then replaced it with a new one 2 days later.When the consumer removed kpp and checked the wound 2 to 3 more days after that, the application site of kpp had become red.As the wound had not formed pus, the consumer applied the kpp which had once used to the wound again.On (b)(6) 2021, the consumer removed kpp because pus leaked from it.On (b)(6) 2021, the consumer purchased a pyostatic agent at a drug store.After the consumer applied it, the pus stopped.On (b)(6) 2021, the consumer visited a dermatologist.As of this reporting, the consumer was using a steroid drug as prescribed the dermatologist.

• Brand Name: BAND AID BRAND KIZU POWER PAD
• 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: 11871236
• MDR Text Key: 266409911
• Report Number: 2214133-2021-00017
• 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: 04/28/2021

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: 04/28/2021
• Initial Date FDA Received: 05/24/2021
• 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