MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND INFECTION DEFENSE LARGE ADHESIVE COVER WITH NEOSPORIN; TAPE AND BANDAGE, ADHESIVE

Model Number 381370055679

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

Patient Problems Contact Dermatitis (4546); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/03/2022

Event Type  Injury  

Event Description

Female consumer reported an event with band aid bandage antibiotic extra large.On (b)(6) 2022, the consumer used the product to aid in the healing of a burn.On (b)(6) 2022, the consumer alleged that she crying in pain due do a bad reaction.A healthcare provider (hcp) was contacted about the experience.The hcp said it was contact dermatitis and prescribed betamethasone dipropionate for the treatment.The consumer also was using unknown steroid cream, extra gauze, and tape to attempt to heal symptoms.Consumer is still experiencing these symptoms.

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 weight, and ethnicity and race were not provided for reporting.This report is for one bab antibiotic extra large 8s usa 381370055679 8137005567usb lot number 0352b.Udi #: (b)(4).Upc #: (b)(4).Lot #: 0352b.Expiration date - 02/01/2024.Device is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.(b)(4).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 february 4, 2022.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 INFECTION DEFENSE LARGE ADHESIVE COVER WITH NEOSPORIN
• 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: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 15469464
• MDR Text Key: 300427993
• Report Number: 8041154-2022-00019
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370055679
• UDI-Public: (01)381370055679(17)240201(10)0352B
• Combination Product (y/n): Y
• 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: 10/10/2022

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 Expiration Date: 02/01/2024
• Device Model Number: 381370055679
• Device Lot Number: 0352B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/03/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 10/10/2022
• Supplement Dates FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Female