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

Model Number 4901730077699

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

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.A2: it was reported that patient age was in her 70s.D1, d2, d3, d4: this report is for (band aid brand kizu power pad (kpp) spot 10ct ap 4901730077699 4901730077699apa 4901730077699apa).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 # 4901730077699 expiration date: 03/21/2026 lot number: 1123c d9: 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.A review of the device history records has been requested.H6: health effect clinical code: e200801- also refers to consumer alleged about "felt like that thin film formed skin, which had not disappeared almost for week, area was shiny, glossy".The consumer used the product for a wound under her nose and reported that after she removed the product ¿a part of the strip remained on the skin¿ and that she had tried various ways including applying a cream and an emulsion, or trying to remove it with hot water, but she could not remove it.Based on overall details available, ¿a part of the strip remained on the skin¿ was interpreted as and coded to device embedded in tissue or plaque (foreign body).¿felt like that a thin film formed on the skin¿ and ¿only the area was shiny and glossy¿ interpreted as description of the event.No direct report of any hcp consult in available information; ¿visit a dermatologist¿ was a futuristic statement.Based on available information, no hcp consult, no significant intervention reported and no other seriousness criteria met.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A female consumer in her 70s fell down and got a wound under her nose and applied band aid brand kizu power pad under her nose.After she removed the product, a part of the strip remained on her skin.The consumer reported she felt a thin film formed on the skin, which had not disappeared for almost a week.Consumer reported she could see the area was shiny and glossy under a light.Consumer reported she tried to remove the product with an application of a cream, an emulsion, oil, lukewarm and hot water.Consumer reported she would seek medical intervention with a dermatologist.The patient is still experiencing symptoms while reporting this event and symptoms have remained the same.There was no further information available for this event.

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 an 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.H2, 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 april 22, 2023.If information is obtained that was not available for the follow-up #1 medwatch, an additional 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 HUNGARY KFT; h-4300 hyirbator; coloplast u.2 ; HU
• Manufacturer Contact: michael connaughton ; 199 grandview rd; skillman, NJ 08558-9418 ; 9086555919
• MDR Report Key: 18354144
• MDR Text Key: 330867305
• Report Number: 2214133-2023-00041
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 4901730077699
• UDI-Public: (01)4901730077699(17)260321(10)1123C
• 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,Followup
• Report Date: 12/19/2023

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: 4901730077699
• Device Lot Number: 1123C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 12/19/2023
• Supplement Dates FDA Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2023
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female