MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC. NEUTROGENA STUBBORN ACNE ULTRA THIN BLEMISH PATCH; DRESSING, WOUND, OCCLUSIVE

Model Number 070501064368

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

Patient Problems Discomfort (2330); Skin Inflammation/ Irritation (4545)

Event Date 12/16/2023

Event Type  Injury  

Event Description

A 17 year old male consumer reported that he experienced discomfort using neutrogena stubborn acne ultra thin blemish patch dots.Consumer reported having a severe irritation near his eyes and forehead.It was reported that the symptoms improved after the patient stopped using the product.Consumer sought medical intervention from physician and given prescribed hydrocortisone cream for treatment and chamomile bags.

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.D1, d2, d3, d4: this report is for one (1) neutrogena stubborn acne ultra thin blemish patch dots 24ct usa 070501064368.D4: udi # (b)(4).Upc #: 070501064368.Expiration date: na.Lot #: 2063c.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: e1720 also refers to consumer alleged having & irritation near eyes and forehead.This event is reported as an overabundance of caution.It was reported that following use of product consumer developed severe irritation near eyes and on forehead and was left with discomfort.The consumer consulted hcp and was treated with topical medication.No direct report of aggravation/worsening of pre-existing condition in available information.Based on available information, no hospitalization, no significant intervention reported.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.Updated information: d4: udi # (b)(4).Upc #: (b)(4).Expiration date: 06/30/2026.Lot #: 2063c.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 july 23, 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: NEUTROGENA STUBBORN ACNE ULTRA THIN BLEMISH PATCH
• 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: michael connaughton ; 199 grandview rd; skillman, NJ 08558-9418 ; 9086555919
• MDR Report Key: 18484277
• MDR Text Key: 332558253
• Report Number: 2214133-2024-00001
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

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: 070501064368
• Device Lot Number: 2063C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2023
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Sex: Male