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

Model Number 381370044444

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

Patient Problems Peeling (1999); Skin Burning Sensation (4540)

Event Date 10/02/2021

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient age at time of event, gender, weight, and ethnicity and race were not provided for reporting.This report is for one (1) bab flexible fabric 1in 100s usa 381370044444 8137004444usa 8137004444usa, lot number 201124.(b)(4), upc - 38137004444, lot number ¿ 201124.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.A review of the device history records has been requested.At this time, this event is being reported with an overabundance of caution.This is 2 of 2 med-watches being submitted as two devices were involved in this event.See medwatch 1000599868-2021-00014.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

Consumer reported an event with band aid flexible fabric bandages.Consumer reported she used the product for a scratch from an iron that burned skin.Consumer alleged she had an extreme reaction from flexible fabric bandages.It burned her skin and took three layers of it.Consumer sought medical attention from the emergency room on (b)(6) 2021 and was treated for event (treatment unknown).This is 2 of 2 med-watches being submitted as two devices were involved in this event.See medwatch 1000599868-2021-00014.The same patient is represented in each medwatch.

Manufacturer Narrative

Johnson & 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 & 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 & johnson consumer, inc.Or its employees that the report constitutes an admission that the device, johnson & johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.H4, h6: 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 24, 2020.If information is obtained that was not available for the follow-up #1 medwatch, an additional follow- up medwatch will be filed as appropriate.

• Brand Name: BAB FLEXIBLE FABRIC 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): 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: 12729911
• MDR Text Key: 282833658
• Report Number: 1000599868-2021-00015
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 38137004444
• UDI-Public: (01)38137004444(10)201124
• 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,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381370044444
• Device Lot Number: 201124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female