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

Model Number 381371192533

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

Patient Problems Peeling (1999); Blister (4537)

Event Date 09/16/2021

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight, and ethnicity and race were not provided for reporting.This report is for one (1) band aid brand infection defense large adhesive cover with neosporin 6ct usa 381371192533 381371192533usa 381371192533usa, lot number 0571b.Udi: (b)(4), upc: 381371192533, lot number: 0571b, exp date: na.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.Device history record has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A consumer reported an event with band aid brand infection defense large adhesive cover with neosporin.Consumer alleged he had a little burn on the side of his leg from dirt bike motor and he got these large adhesive covers with neosporin already put in from band-aid.He took it off after 9 hours at work and it pulled up the skin under the adhesive.The consumer stated that it blistered and sought medical attention.The health care professional recommended him to keep the wound covered while at work with tape and gauze, and was prescribed an antibiotic ointment for treatment.Consumer symptoms improved after the patient stopped using the product.The consumer is still experiencing 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 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.Additional data: c7 - expiration date - february 3, 2023.D4 - expiration date - february 3, 2023.Corrected data: udi: d4: (b)(4).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 26, 2021.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
• MDR Report Key: 12601308
• MDR Text Key: 282205653
• Report Number: 8041154-2021-00035
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381371192533
• UDI-Public: (01)381371192533(10)0571B
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

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: 02/03/2023
• Device Model Number: 381371192533
• Device Lot Number: 0571B
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 10/08/2021
• Supplement Dates Manufacturer Received: 10/27/2021
• Supplement Dates FDA Received: 10/29/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR