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

Model Number 4901730021913

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

Patient Problems Fever (1858); Unspecified Infection (1930); Peeling (1999)

Event Date 09/16/2020

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 large ap 4901730021913 0037131786apa).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).Upc #: 4901730021913, lot #: 3489c, expiration date: n/a, udi #: (b)(4).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 december 5, 2019.(b)(4).This is 2 of 2 med-watches being submitted as two devices were involved in this event.See medwatch 2214133-2020-00040.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)-year-old mother (reporter) reported about her (b)(6)-year-old daughter an event with band aid brand kizu power pad large.On (b)(6) 2020, the consumer fell and got a wound on her right knee.The reporter applied kpp to the wound and replaced kpp with a new one several times each time exudate fluid leaked from kpp.On (b)(6) 2020, when the reporter took the consumer to a hospital because the consumer had a fever, the reporter was told the consumer might be infected with streptococcus.On (b)(6) 2020, when the reporter removed half of the kpp, a thin layer of white skin peeled off along with the kpp and odorized exudate fluid with blood leaked from the wound.The reporter put the kpp back in place at that time and removed it when the reporter had the consumer take a shower.This is 2 of 2 med-watches being submitted as two devices were involved in this event.See medwatch 2214133-2020-00040.The same patient is represented in each medwatch.

• 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.; coloplast u.2 ; HU
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 10670672
• MDR Text Key: 213259407
• Report Number: 2214133-2020-00041
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 4901730021913
• UDI-Public: (01)4901730021913(10)3489C
• 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: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• 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: 3489C
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR