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

Model Number 381370044086

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

Patient Problems Itching Sensation (1943); Rash (2033); Skin Inflammation (2443)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient identifier, age at time of event, sex, weight, and ethnicity and race were not provided for reporting.This report is for one (1) bab tough strips 20s usa 381370044086, 8137004408usa.Lot # is not available.Udi # is (b)(4).Device is not expected to be returned for manufacturer review/investigation.Device evaluation 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.

Event Description

A consumer reported an event with bab tough strips.Consumer stated that within minutes of the use of bandage and allergic reaction occurred.The consumer experienced itching and the next day had a rectangle on skin that was the size and shape of the bandage.Consumer sought medical attention from a health care professional, a dermatologist, as the rectangle became an inflamed, itchy rash.Eight days later the consumer is still experiencing symptoms.

• Brand Name: BAB TOUGH STRIPS
• 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; sao jose dos campos ; BR
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 10356544
• MDR Text Key: 203289365
• Report Number: 8041154-2020-00018
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370044086
• UDI-Public: (01)381370044086(10)NI
• 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: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381370044086
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention