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 Problem Erythema (1840)

Event Date 06/03/2022

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient id, weight, ethnicity: patient identifier, weight, and ethnicity and race were not provided for reporting.Brand name, common device name, manufacture name, city, and state, model #: 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: 2531c.Expiration date: (b)(6) 2024.Device is not expected to be returned for manufacturer review/investigation.Concomitant medical products and therapy dates: drug: prednisone (prednisolone, steroid); unknown therapy dates.Drug: bayaspirin (aspirin); unknown therapy dates.Drug: careload (beraprost sodium controlled-release tablet); unknown therapy dates.Drug: epadel (ethyl icosapentate); unknown therapy dates.Drug: revatio (sildenafil citrate); unknown therapy dates.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) 2021.This report is for band aid brand kizu power pad (kpp) large.See medwatch 2214133-2022-00032 for band aid brand kizu power pad (kpp) regular.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 (b)(6) female consumer reported an event with (b)(4)) large.On (b)(6) 2022, the consumer injured the inner side under the right wrist, and a cut developed.She applied kpp large to the affected area.On the following day, (b)(6) 2022, redness was slightly noted at the site where the product had been applied, but she replaced the product with kpp regular to go out.On (b)(6) 2022, she removed kpp regular at night because of red rash.On (b)(6) , she visited a dermatologist, who told her that she should apply antebate (betamethasone butyrate propionate) prescribed before to the affected area because of the development of rash.She applied the drug.On (b)(6) 2022, she noticed that a brown mark of the shape of kpp had remained on the skin.The consumer is still experiencing the symptoms.This report is for (b)(4) large.See medwatch (b)(4) for (b)(4) regular.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: 14879734
• MDR Text Key: 295123443
• Report Number: 2214133-2022-00033
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 4901730021913
• UDI-Public: (01)4901730021913(17)240831(10)2531C
• 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: 06/08/2022

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
• Device Model Number: 4901730021913
• Device Lot Number: 2531C
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/08/2022
• Initial Date FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: BAYASPIRIN; CARELOAD; EPADEL; PREDNISONE; REVATIO
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female