MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC. BAND AID BRAND SENSITIVE SKIN BANDAGES; TAPE AND BANDAGE, ADHESIVE

Model Number 381372020071

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/02/2024

Event Type  Injury  

Event Description

A female consumer of unknown age reported she has been healing from a skin biopsy with band aid brand sensitive skin bandage for the past week.Consumer reported having an allergic reaction which she suspected was from something within the adhesive of the product.Consumer reported having red and itchy patches where the adhesive was attached.Consumer sought medical intervention whereby the doctor stated the consumer needed to keep the wound covered for 24 hours and physician recommended unknown hydrocortisone and an unknown anti-itch cream on the affected area and attempted to use benadryl cream to moisturized the area.This emdr is for (band aid brand sensitive skin bandages).See medwatch 1000599868-2024-00003 for (bab flexible fabric assorted).The same patient 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 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.Patient age, weight and ethnicity and race were not provided for reporting.This report is for one (1) band aid brand sensitive skin bandages 20ct usa 381372020071 381372020071usa 381372020071usa, lot/ctrl # 3313b d4: udi #: (b)(4).Upc # 381372020071 expiration date: ni lot # 3313b device is not expected to be returned for manufacturer review/investigation 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.Health effect clinical code: e0402 also refers to consumer alleged "allergy on skin (redness and itchy patches subsume)".E2402 also refers to consumer "intentional misuse/off-label use" of the product.This emdr is for (band aid brand sensitive skin bandage).See medwatch 1000599868-2024-00003 for (bab flexible fabric assorted).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.

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.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 november 27, 2023.Raw material and component records were reviewed and were found acceptable.This emdr is for (band aid brand sensitive skin bandage).See medwatch 1000599868-2024-00003 for (bab flexible fabric assorted).The same patient is represented in each medwatch.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 SENSITIVE SKIN BANDAGES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC.; 199 grandview rd; skillman NJ 08558 9418
• Manufacturer (Section G): BRAZIL CONSUMER; rodovia presidente dutra km 15; são josé dos campos ; BR
• Manufacturer Contact: michael connaughton ; 199 grandview rd; skillman, NJ 08558-9418 ; 9086555919
• MDR Report Key: 19083048
• MDR Text Key: 339875844
• Report Number: 8041154-2024-00004
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381372020071
• UDI-Public: (01)381372020071(10)3313B
• 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: 05/02/2024

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: 381372020071
• Device Lot Number: 3313B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female