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

Model Number 381370044246

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

Patient Problems Burn(s) (1757); Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/08/2021

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Weight and ethnicity were not provided for reporting.This report is for (bab tough strips extra large 10s usa 381370044246 8137004424usa 8137004424usa).Udi #: (b)(4).Upc #: 381370044246, expiration date: na,lot #: 191130.Concomitant medical products: 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 november 30, 2019.If information is obtained that was not available for the initial medwatch, an additional follow-up medwatch will be filed as appropriate.

Event Description

Consumer reported an event with band-aid tough strips extra large.Consumer reported that on (b)(6) 2021 she used the product to cover a pimple on her leg so that her paints would not irritate it.Within an hour or two, the consumer started having intense soreness on her leg.The consumer removed the product and alleged a chemical burn.Consumer stated that she was burned so badly that it had puss and a little blood at the site.The consumer sought medical attention from a health care professional (hcp).Her hcp prescribed antibiotic topical (apply the topical twice daily until the pus stops and the wound heals), told her to cover it with gauze and wrap her leg with a bandage.On (b)(6) 2021, the symptoms resolved.

• Brand Name: BAB TOUGH STRIPS
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC.; 199 grandview road; skillman NJ 08558 9418
• Manufacturer (Section G): SHANGHAI JOHNSON & JOHNSON LTD; 120 nan ya road; minghang, shanghai 20024 5; CH 200245
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 11708785
• MDR Text Key: 247157529
• Report Number: 1000599868-2021-00003
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370044246
• UDI-Public: (01)381370044246(10)191130
• 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: 03/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381370044246
• Device Lot Number: 191130
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 03/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2019
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR