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

Model Number 381370048480

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

Patient Problems Reaction (2414); Caustic/Chemical Burns (2549); No Code Available (3191)

Event Date 07/10/2020

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight, and ethnicity and race were not provided for reporting.Udi #: (b)(4).Upc #: 381370048480, lot #: 3189b, exp: na this is a band-aid variety pack (water block clear, tough strips, & cushion-care sport strip) 30 ct.Lot3189b.Consumer is complaining about the water block clear.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 nov 17, 2019.(b)(4).This is two of two medwatches being submitted as two devices were involved in this event.See medwatch 8041154-2020-00019.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 parent reported her daughter (b)(6) had an adverse reaction to water block bandages.Product was used for a cat scratch on (b)(6) 2020.The mother placed two water block band-aids vertically on the cut.On (b)(6) 2020, the mother noticed red underneath one of the band-aids.The mother pulled the band-aids off to reveal two burns - right under where the pad portion of the band-aid was placed.The mother has been placing neosporin on the burns and was hoping it went away.Urgent care was given on (b)(6) 2020, where the doctor prescribed burn cream and suggested to cover the burns with gauze.The burns must get significantly better within 5 days or she will have to be seen again.Consumer is still experiencing symptoms.There are two red patches, the size of the bandage pads, on her forearm.The skin is flaking off and they are rough to the touch.Consumer states the doctor confirmed that they are chemical burns.This is two of two medwatches being submitted as two devices were involved in this event.See medwatch 8041154-2020-00019.The same patient is represented in each medwatch.

• Brand Name: BAB WATER BLOCK CLEAR
• 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: 10361170
• MDR Text Key: 207916420
• Report Number: 8041154-2020-00020
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370048480
• UDI-Public: (01)381370048480(10)3189B
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 381370048480
• Device Lot Number: 3189B
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 03 YR