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 Problems Skin Tears (2516); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/13/2023

Event Type  Injury  

Event Description

A female consumer reported while she was making dinner, her wrist hit the frying pan, and she got a burn wound which soon became a blister like a welt.The next day, the blister broke, and about 4cm x 5mm of her skin was exposed.She went to a drug store and was recommended the band aid brand kizu power pad (kpp) large by a store staff, and therefore, she purchased and used it.When she read the package insert after applying the product to her wound, she found it was written that the product could be used for wounds only on the day of injury.Since she became worried whether it was no problem to use the product for a burn wound like hers, she removed the product.When she removed it, the skin peeled off excessively, and the exposed skin area spread out to about 4 cm x 2 cm.When she visited her dermatologist, she was told to stop using the product.She was also instructed to apply an anti-suppuration ointment for a week and come to see the dermatologist again.When she visited the dermatologist again, she was told that she did not need to apply the ointment anymore because her wound had gotten better.

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.A2: patient age - it was reported that patient was in her 60s at the time of event.A4, a5: patient 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.Exp date: mar-31-2025.Lot number: 1512c.D10: device is not expected to be returned for manufacturer review/investigation.H3, 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 may 31, 2022.H6: health effect clinical code: e2402 refers to consumer "intentional misuse/off-label use" of the product.E1721 also refer to consumer alleged about "the skin peeled off excessively, and the exposed skin area spread out to about 4 cm x 2 cm".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: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 16919261
• MDR Text Key: 315091900
• Report Number: 2214133-2023-00013
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 4901730021913
• UDI-Public: (01)4901730021913(17)250331(10)1512C
• 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: 04/21/2023

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
• Device Lot Number: 1512C
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female