MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC. BAB FLEXIBLE FABRIC BANDAGES; TAPE AND BANDAGE, ADHESIVE

Model Number 381371150786

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 flexible fabric 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.It was reported that the symptoms improved after the patient stopped using the product.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 moisturize the area.This emdr is for (bab flexible fabric assorted).See medwatch 8041154-2024-00004 for (band aid brand sensitive skin bandage).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) bab flexible fabric assorted (b)(4) ct usa 381371150786 8137115078usa 8137115078usa, lot/ctrl # 211104 udi #: (b)(4).Upc # 381371150786 expiration date: ni lot # 211104 device is not expected to be returned for manufacturer review/investigation 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 4, 2021.Health effect clinical code: e0402 also refers to consumer alleged " allergy on skin (redness and itchy patches subsume) & quot.E2402 also refers to consumer "intentional misuse/off-label use" of the product.This emdr is for (bab flexible fabric assorted).See medwatch 8041154-2024-00004 for (band aid brand sensitive skin bandages).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.

• Brand Name: BAB FLEXIBLE FABRIC BANDAGES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC.; 199 grandview rd; skillman NJ
• Manufacturer (Section G): SHANGHAI JOHNSON & JOHNSON LTD; 120 nan ya road; minghang, shanghai 20024 5; CH 200245
• Manufacturer Contact: michael connaughton ; 199 grandview rd; skillman, NJ 08558-9418 ; 9086555919
• MDR Report Key: 19066408
• MDR Text Key: 339676278
• Report Number: 1000599868-2024-00003
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381371150786
• UDI-Public: (01)381371150786(10)211104
• 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: 03/26/2024

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: 381371150786
• Device Lot Number: 211104
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female