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 Erythema (1840); Fluid Discharge (2686); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/24/2023

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.A4, a5: patient weight, and ethnicity and race were not provided for reporting.B5: no details provided regarding hospital admission.D1, d2, d3, d4: this report is for (band aid brand kizu power pad (kpp) large 6ct ap (b)(4)).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 (b)(4)).Lot number was not available for reporting.D4: udi#: (b)(4).Upc: (b)(4).Lot number: ni; expiration 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 codes: e2315 also refers to consumer alleged about "ocher-colored parts like pus, the fluid leaked from it".E2402 refers to consumer "intentional misuse/off-label use" of the product.This is one of two medwatches being submitted as two devices were involved in this event.See medwatch 2214133-2023-00019.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 male consumer got a scratch with a burn on his left arm on (b)(6) 2023.He stated that the wound was pure white, not reddish.On (b)(6) 2023, he used the band aid brand kizu power pad (kpp) large for the wound.On (b)(6) 2023, when he tried to remove the product because the fluid leaked from it, he found that the wound turned red and there were some parts that had turned ocher like pus.Therefore, he removed the product.He received treatment at a hospital and was prescribed gentacin ointment (gentamicin sulfate).After he used the ointment for the wound, the redness of the wound and the thing like pus disappeared.As of this reporting, he was not using the product because the wound was getting better.However, when he took a bath, the wound was weeping.This is one of two medwatches being submitted as two devices were involved in this event.See medwatch 2214133-2023-00019.The same patient is represented in each medwatch.

• 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: 17107627
• MDR Text Key: 316998018
• Report Number: 2214133-2023-00018
• 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: 05/26/2023

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: 05/26/2023
• Initial Date FDA Received: 06/12/2023
• 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; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male