MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC J&J BAND AID BRAND CUSHION CARE SPORTS STRIP; TAPE AND BANDAGE, ADHESIVE

Model Number 381370047230

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

Patient Problem Local Reaction (2035)

Event Date 10/30/2022

Event Type  Injury  

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 at time of event, weight, and ethnicity and race were not provided for reporting.This report is for one (1) bab sport strips extra wide 30s usa 381370047230 8137004723usa, lot number 1448b.Udi #: (b)(4).Upc #: 381370047230.Lot #: 1448b.Expiration date: na.Concomitant medical products: 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.This is two of two medwatches being submitted as two devices were involved in this event.See medwatch 8041154-2022-00035.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.

Event Description

A female consumer reported an event with extra wide band-aid sport strips.Consumer reported she used the bandages and had a reaction to it.It was reported that, consumer applied two band-aids for her injury on (b)(6) 2022.On (b)(6) 2022, the consumer had a reaction.The symptoms improved and stopped after the patient stopped using the product on (b)(6) 2022.Consumer visited health care professional and was administered unknown hydrocortisone cream for treatment.The symptoms has resolved.This is two of two medwatches being submitted as two devices were involved in this event.See medwatch 8041154-2022-00035.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 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 may 24, 2018.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: J&J BAND AID BRAND CUSHION CARE SPORTS STRIP
• 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: 15814807
• MDR Text Key: 303818188
• Report Number: 8041154-2022-00036
• Device Sequence Number: 1
• Product Code: KGX
• 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: 12/03/2022

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: 381370047230
• Device Lot Number: 1448B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 12/03/2022
• Supplement Dates FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2018
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female