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

Model Number 4901730016322

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

Patient Problems Erythema (1840); Local Reaction (2035); Skin Discoloration (2074); Impaired Healing (2378)

Event Type  Injury  

Event Description

A consumer reported an event with band aid brand kpp (kizu power pad) bandage on (b)(6) 2022.Consumer stated that in (b)(6) 2021, the consumer applied kpp on the right forefinger because of care for chapped skin.The consumer kept the product on for three or four days.The consumer discontinued the use of the product and visited a dermatologist because redness was noted on the area where the product had been applied.The consumer only used one strip of the product once.The consumer used a unknown medicine prescribed by the dermatologist, and the redness healed.However, the finger was cold and white, which did not heal for a long time.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient identifier, age/dob, gender, weight, and ethnicity and race were not provided for reporting.Brand name, common device name, manufacturer name, city, and state, lot #: this report is for (band aid brand kizu power pad (kpp) 6ct ap 4901730016322 4901730016322apa 4901730016322apa).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: (b)(4).Upc # 4901730016322, lot # 1940c.Expiration date: 06/30/2023.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 july 12, 2020.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: 14655908
• MDR Text Key: 294662164
• Report Number: 2214133-2022-00026
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 4901730016322
• UDI-Public: (01)4901730016322(17)230611(10)1940C
• 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: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/11/2023
• Device Model Number: 4901730016322
• Device Lot Number: 1940C
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention