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

Model Number 070501064375

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

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 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.A4, a5: weight, and ethnicity and race were not provided for reporting.D1, d2, d3, d4: this report is for one (neutrogena stubborn acne ultra thin blemish patch assorted 16ct usa 070501064375 (b)(6), lot/ctrl # 2422c).D4: udi #: (b)(4).Upc #: 070501064375 lot #: 2422c exp date: na 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.Device history records review has been requested.H6: health effect clinical code: e0402 also refers to consumer alleged for "allergic reaction and face turned red and broke out".This is one of five medwatches being submitted as five devices were involved in this event.See medwatches 2214133-2024-00010; 2214133-2024-00011; 2214133-2024-00012; 2214133-2024-00013; 2214133-2024-00014.The same patient and event 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 reported an allergic reaction with neutrogena stubborn acne ultra thin blemish patches assorted.It was reported that consumer applied five circles one time, five weeks ago on his face for minor blemishes and it caused an immediate allergic reaction.Consumer reported that his face turned red and broke out.Consumer sought medical intervention and was treated with an unspecified antibiotic for three weeks.Consumer¿s symptoms have worsened at the time of this reporting.This is one of five medwatches being submitted as five devices were involved in this event.See medwatches 2214133-2024-00010; 2214133-2024-00011; 2214133-2024-00012; 2214133-2024-00013; 2214133-2024-00014.The same patient and event is represented in each medwatch.

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.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 march 23, 2022.This is one of five follow-up medwatches being submitted as five devices were involved in this event.See medwatches 2214133-2024-00011; 2214133-2024-00012; 2214133-2024-00013; 2214133-2024-00014.The same patient and event is represented in each medwatch.If information is obtained that was not available for the follow-up 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 road; skillman NJ 08558 9418
• Manufacturer (Section G): COLOPLAST; coloplast hungary kft; h-4300 nyirbator; coloplast ; HU
• Manufacturer Contact: michael connaughton ; 199 grandview rd; skillman, NJ 08558-9418 ; 9086555919
• MDR Report Key: 18950197
• MDR Text Key: 338250433
• Report Number: 2214133-2024-00010
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 070501064375
• UDI-Public: (01)070501064375(10)2422C
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 070501064375
• Device Lot Number: 2422C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male