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

Model Number 4901730021906

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

Patient Problems Erythema (1840); Itching Sensation (1943)

Event Type  Injury  

Event Description

The consumer reported an event with band aid brand hydroseal bandage all purpose.The consumer applied the band-aid around the end of (b)(6) 2023 for scratch wound from rubbing with bath towels and itching occurred within a day.When consumer removed band-aid hydro seal bandage, consumer noticed that the application site turned red in the shape of band-aid hydro seal bandage.The consumer consulted a dermatologist and reported they were experiencing itchiness and redness at the application site while using band-aid hydro seal bandage.The dermatologist prescribed a topical medicine containing steroids and conveyed to consumer how to remove the band-aid hydro seal bandages as soon as itching occurs and to soak band-aid hydro seal bandages in the bath before removing it.It was reported that consumer symptoms resolved after she applied the medicine.

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.A1, a2, a3, a4, a5: patient identifier, patient age, gender, weight, and ethnicity and race were not provided for reporting.D1, d2, d3, d4: this report is for one (1) band aid brand kizu power pad (kpp) regular 10ct ap 4901730021906, 4901730021906apb, 4901730021906apb, lot number ni.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).D4: (b)(4).Upc #4901730021906.Expiration date: na.Lot# ni.D10: device is not expected to be returned for manufacturer review/investigation.H3, h4, h6: device evaluation/investigation could not be completed.No conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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: michael connaughton ; 199 grandview rd; skillman, NJ 08558-9418 ; 9086555919
• MDR Report Key: 17887422
• MDR Text Key: 325124266
• Report Number: 2214133-2023-00033
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 4901730021906
• UDI-Public: (01)4901730021906(10)NI
• 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: 09/13/2023

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: 4901730021906
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: VITAMINS FOR CHLOASMA.
• Patient Outcome(s): Required Intervention