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

Model Number 381370056850

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

Patient Problems Dyspnea (1816); Itching Sensation (1943); Skin Burning Sensation (4540); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Ethnicity and race were not provided for reporting.This report is for one (1) band aid brand adhesive bandages flexible fabric strips 10ct usa 381370056850, lot/ctrl # 210517.Udi #: (b)(4).Upc #: 381370056850.Lot #:210517.Exp date:na.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.Device history records review has been requested.This is 4 of 5 med-watches being submitted as five potential devices were involved in this event.See medwatches: 1000599868-2022-00004, 8041154-2022-00002, 1000599868-2022-00005, 1000599868-2022-00007.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 consumer reported using bab flexible fabric band aids on her chest after having a surgery in (b)(6) 2021.Consumer stated she developed itching on/in chest and throat.Consumer stated she could not breath and that the products burned her chest.Consumer sought medical intervention and was treated by physician with inhalers and steroids via oral administration.There is no additional information with regard to outcome for this consumer.This is 4 of 5 med-watches being submitted as five potential devices were involved in this event.See medwatches: 1000599868-2022-00004, 8041154-2022-00002, 1000599868-2022-00005, 1000599868-2022-00007.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 may 17, 2021.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 road; skillman NJ 08558 9418
• Manufacturer (Section G): J&J SHANGHAI, CHINA; 120 nan ya road; minghang, shanghai ; CH
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 13892251
• MDR Text Key: 289957157
• Report Number: 1000599868-2022-00006
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370056850
• UDI-Public: (01)381370056850(10)210517
• 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: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381370056850
• Device Lot Number: 210517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 06/02/2022
• Date Device Manufactured: 05/17/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female