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 Problem Hypersensitivity/Allergic reaction (1907)

Event Date 10/28/2023

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.D1, d2, d3, d4: this report is for one (1) neutrogena stubborn acne ultra thin blemish patch dots 24ct usa 070501064368 070501064368usa 070501064368usa, lot number ni.D4: udi #(b)(4).Upc #070501064368.Expiration date: na.Lot #ni.D9: device is not expected to be returned for manufacturer review/investigation.D10: other concomitant products (non-device) used: neutrogena hydro boost hydrating gel cleanser fragrance free 7.8oz dosage: approx pea sized amount.Product start date: (b)(6) 2023.Last use date: (b)(6) 2023.Neutrogena hydro boost water gel 1.7oz.Dosage: approx pea sized amount.Product start date: (b)(6) 2023.Last use date: (b)(6) 2023.Neutrogena clear face breakout free oil free sunscreen broad spectrum spf50 3oz.Dosage: approx pea sized amount.Product start date: (b)(6) 2023.Last use date: (b)(6) 2023.Neutrogena healthy skin liquid makeup spf20 1oz classic ivory 10.Product start date: (b)(6) 2023.Last use date: (b)(6) 2023.Neutrogena clear complexion antioxidant gummy with zinc strawberry 60ct.Dosage: 1 pc.Product start date: (b)(6) 2023.Last use date: (b)(6) 2023.Neutrogena stubborn marks pm treatment 1oz.Dosage: approx pea sized amount.Product start date: (b)(6) 2023.Last use date: (b)(6) 2023.Neutrogena stubborn acne am treatment 2oz.Dosage: approx pea sized amount.Product start date: (b)(6) 2023.Last use date: (b)(6) 2023.Neutrogena stubborn texture daily cleanser 6.3oz.Dosage: approx pea sized amount.Product start date: (b)(6) 2023.Last use date: (b)(6) 2023.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: e0402 also refers to consumer alleged about "allergic reaction (hives subsumed)¿.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A 22 year old female consumer reported that she started using neutrogena stubborn acne ultra thin blemish patch dots for her face on (b)(6) 2023.Consumer experienced allergic reaction that developed into hives on (b)(6) 2023.As per consumer, she used other non device products at the same time that she alleged could have caused or contributed to the symptoms.Consumer reported that she went to urgent care and health case professional (hcp) recommended to apply a cream and gave her an unknown steroid shot/injection.Consumer also mentioned that symptoms improved after she stopped using the product.

• 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: 18162136
• MDR Text Key: 328426435
• Report Number: 2214133-2023-00035
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 070501064368
• UDI-Public: (01)070501064368(10)NI
• 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
• Report Date: 11/01/2023

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: 070501064368
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: NEUTROGENA HEALTHY SKIN LIQUID MAKEUP SPF20; NEUTROGENA HYDRO BOOST HYDRATING GEL CLEANSER; NEUTROGENA HYDRO BOOST WATER GEL; NEUTROGENA STUBBORN ACNE AM TREATMENT; NEUTROGENA STUBBORN MARKS PM TREATMENT; NEUTROGENA STUBBORN TEXTURE DAILY CLEANSER; NTG CLEAR COMPLEXION ANTI-O GUMMY W ZINC; NTG CLEAR FACE BREAKOUT FREE OIL FREE SUNSCREEN; SEE H10 FOR FULL DETAILS
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Sex: Female