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

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

Patient Problems Erythema (1840); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 unspecified ap notapplicable rgebabkapa rgebabkapa).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: upc number, lot number and udi number are not available.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: e2402 refers to consumer "intentional misuse/off-label use" of the product.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Consumer reported an event with unspecified band aid brand kizu power pad.About two weeks prior to this reporting, the consumer had a mole removed by a plastic surgeon.According to the plastic surgeon's instruction, the consumer had kept the product applied while replacing it several times to the wound.One week after the consumer started using the product, the area around the wound became bright red and swollen in the shape of the product.Therefore, the consumer stopped using it.The consumer consulted with the plastic surgeon, and was prescribed an unknown ointment and had been applying it to the site.The redness was fading, but some parts had not healed.

• 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: 17189707
• MDR Text Key: 317728708
• Report Number: 2214133-2023-00020
• Device Sequence Number: 1
• Product Code: NAD
• 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
• 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