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 Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

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, age at time of event, gender, weight, and ethnicity and race were not provided for reporting.D1, d2, d3, d4: this report is for (band aid brand kizu power pad (kpp) large 6ct ap 4901730021913 4901730021913apb 4901730021913apb).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: udi#: (b)(4).Upc#: 4901730021913.Lot#: ni.Exp date: 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.H6: health effect clinical code: e0402 also refers to consumer alleged about "allergy on skin (subsumed rash)".If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A pharmacy employee reported an event with a consumer regarding large band aid brand kizu power pad (kpp).A consumer got a rash when using the product.The consumer visited a dermatologist and was told that there was a possibility that an allergy occurred with the ingredients of the product and was instructed to undergo a patch test.

• 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: 17189760
• MDR Text Key: 317729112
• Report Number: 2214133-2023-00021
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 4901730021913
• UDI-Public: (01)4901730021913(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: 06/06/2023

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: 4901730021913
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention