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

Model Number 4901730021913

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

Patient Problems Cellulitis (1768); Scar Tissue (2060)

Event Type  Injury  

Manufacturer Narrative

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) large 6ct 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 (b)(4)).Udi #: (b)(4).Upc: (b)(4).Lot number: 2858c.Expiration date: 09/30/2021.Concomitant medical products: device is not expected to be returned for manufacturer review/investigation.Device history records review was completed.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 and product was manufactured per specification.The product was manufactured on (b)(6) 2018.Causality assessed as not related as cellulitis is bacterial infection and scar was formed as due to cellulitis.This is 2 of 2 med-watches being submitted as two devices were involved in this event.See medwatch 2214133-2022-00023.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.

Event Description

A female consumer reported an event regarding band aid brand kpp (kizu power pad) bandages.On (b)(6) 2022, a female consumer applied kpp to a right shin injury.On (b)(6) 2022, pain developed, and redness was noted around the wound.Therefore, she replaced the product with new one.On (b)(6) 2022, she visited the hospital.When the product was removed, a doctor of the hospital told the consumer that cellulitis had developed.Sofuratulle (fradiomycin sulfate) was applied to the affected area for treatment.On (b)(6) 2022, she received an antibiotic drip at the hospital because pain did not subside.On (b)(6) 2022, she received an antibiotic drip again.As of this reporting, the symptom subsided, but a scar remained on the skin.Although she had been using the product for many years, no events had occurred previously.This is 2 of 2 med-watches being submitted as two devices were involved in this event.See medwatch 2214133-2022-00023.The same patient is represented in each medwatch.

• 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: 14592188
• MDR Text Key: 293275402
• Report Number: 2214133-2022-00024
• 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: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2021
• Device Model Number: 4901730021913
• Device Lot Number: 2858C
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2018
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 38 YR
• Patient Sex: Female