MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND TRU STAY CLEAR BANDAGES; ADHESIVE BANDAGE

Model Number 381370047087

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

Patient Problems Urticaria (2278); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Consumer reported an event with band aid brand tru stay clear spot bandage via social media.Consumer reported he/she has celiac disease and he/she used one band aid bandage.Consumer stated he/she are breaking out in hives and his/her throat is swelling shut.Consumer stated he/she had to stay awake and have an epipen ready to use.Consumer did not seek medical intervention or receive treatment.No additional details have been provided.

Manufacturer Narrative

Johnson & amp; 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 & amp; 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 & amp; johnson consumer, inc.Or its employees that the report constitutes and admission that the device, johnson & amp; 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 information was not provided for reporting.This report is for one (1) band aid brand tru stay clear spot bandages 50ct usa 381370047087 381370047087 usa, lot number is not available.Udi #: (b)(4).Upc #: 381370047087.Lot #: ni.Exp.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.Device history records review could not be completed without lot number.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BAND AID BRAND TRU STAY CLEAR BANDAGES
• Type of Device: ADHESIVE BANDAGE
• 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: 15825884
• MDR Text Key: 303926014
• Report Number: 8041154-2022-00039
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370047087
• UDI-Public: (01)381370047087
• 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: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381370047087
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other