MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND TRU STAY PLASTIC BANDAGES; TAPE AND BANDAGE, ADHESIVE

Model Number 381370056355

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

Patient Problems Rash (2033); Local Reaction (2035)

Event Date 08/19/2022

Event Type  Injury  

Event Description

A female consumer (mother) reported that her daughter used band aid brand tru stay plastic bandages and had a terrible reaction.The consumer stated that her daughter got a rash and it blistered a little.It was reported that, the symptoms improved after the patient stopped using the product.The patient was still experiencing the symptoms while reporting this event.The consumer contacted health care professional (hcp) about the experience and was prescribed to use mometasone furoate ointment for treatment.This is 3 of 4 med-watches being submitted as four devices were involved in this event.See medwatch 8041154-2022-00012, 8041154-2022-00013, 8041154-2022-00015.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 weight and ethnicity and race were not provided for reporting.This report is for one (1) band aid brand tru stay plastic bandages 60ct usa (b)(4) lot number 3231b.Udi #: (b)(4), upc #: 381370056355, lot #: 3231b, exp: na.Device is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.(b)(4).This is 3 of 4 med-watches being submitted as four devices were involved in this event.See medwatch 8041154-2022-00012, 8041154-2022-00013 & 8041154-2022-00015.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 19,2021.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 TRU STAY PLASTIC 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: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 15438013
• MDR Text Key: 300045147
• Report Number: 8041154-2022-00014
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370056355
• UDI-Public: (01)381370056355(10)3231B
• 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: 10/04/2022

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 Model Number: 381370056355
• Device Lot Number: 3231B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/16/2022
• Supplement Dates Manufacturer Received: 10/04/2022
• Supplement Dates FDA Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR
• Patient Sex: Female