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

Model Number 4901730080163

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

Patient Problems Local Reaction (2035); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

A male consumer reported an event with band aid brand kpp (kizu power pad) bandages.The consumer had been applying band aid brand kpp (kizu power pad) bandage for about one month for care for the left elbow which had become black with bleeding due to bedsore.While replacing the product with new ones every day during taking a bath after he stopped bleeding.After that, the areas which had turned black or whose skin had peeled completely healed, but a part of the skin got raised.Consumer saw a dermatologist on (b)(6) 2022 and was instructed to stop using kpp and an ointment called azunol (dimethyl isopropylazulene) was prescribed.This is two of two med-watches being submitted as two devices were involved in this event.See medwatch 2214133-2022-00051.The same patient is represented in each medwatch.

Manufacturer Narrative

Johnson & johnson consumer, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which johnson & johnson consumer, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, johnson & johnson consumer, inc.Or its employees that the report constitutes and admission that the device, johnson & johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.Patient weight, and ethnicity and race were not provided for reporting.This report is for (band aid brand kizu power pad (kpp) knee & elbow 3ct ap 4901730080163 4901730080163apa 4901730080163apa).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: 4901730080163.Lot number: 1731c.Expiration date: february 29, 2034.Concomitant medical products: 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.A review of the device history records has been requested.(b)(4).This is two of two med-watches being submitted as two devices were involved in this event.See medwatch 2214133-2022-00051.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.

Manufacturer Narrative

Johnson & johnson consumer, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which johnson &; johnson consumer, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, johnson & johnson consumer, inc.Or its employees that the report constitutes an admission that the device, johnson & johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.Corrected data: d4: udi- (b)(4).Expiration date: 03/31/2024.H4, h6: 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 april 1, 2021.If information is obtained that was not available for the follow-up #1 medwatch, an additional 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: 15986809
• MDR Text Key: 305530842
• Report Number: 2214133-2022-00052
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 4901730080163
• UDI-Public: (01)4901730080163(17)240331(10)1731C
• 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,Followup
• Report Date: 12/23/2022

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 Expiration Date: 03/31/2024
• Device Model Number: 4901730080163
• Device Lot Number: 1731C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/25/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 12/23/2022
• Supplement Dates FDA Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male