MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAB CLEAR BANDAGES; TAPE AND BANDAGE, ADHESIVE

Model Number 381370047087

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

Patient Problems Itching Sensation (1943); Swelling (2091); Reaction (2414)

Event Date 07/26/2020

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient date of birth, weight and ethnicity were not provided for reporting.This report is for one bab clear spots 50s usa 381370047087 8137004708usb.Udi #: (b)(4).Upc #: (b)(4), lot #: 3389b, exp date: na.Device is not expected to be returned for manufacturer review/investigation 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 december 4, 2019 (b)(4).If information is obtained that was not available for this initial medwatch, an additional follow-up medwatch will be filed as appropriate.

Event Description

A female consumer reported an event with bab clear spots 50s usa.The consumer applied one band-aid and alleged having a reaction to the adhesive on the left side of the face on (b)(6) 2020.Consumer visited dermatologist who confirmed allergic reaction.The consumer was prescribed an ointment for treatment.The consumer is still experiencing symptoms, such as, itching, redness, little bumps and swollen area.

• Brand Name: BAB CLEAR 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: 10448874
• MDR Text Key: 204353547
• Report Number: 8041154-2020-00025
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370047087
• UDI-Public: (01)381370047087(10)3389B
• 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: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381370047087
• Device Lot Number: 3389B
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 08/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention