MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC J&J BAND AID BRAND CUSHION CARE SPORTS STRIP; TAPE AND BANDAGE, ADHESIVE

Model Number 381370047230

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

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 and 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.Patient weight, and ethnicity and race were not provided for reporting.This report is for one (1) j&j band aid brand cushion care sports strip 30ct usa, 381370047230 381370047230usa, lot number 0479b.Udi #: (b)(4).Upc #: 381370047230.Lot #: 0479b.Expiration date : na.Concomitant medical products: 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.(b)(4).This is one of two medwatches being submitted as two devices were involved in this event.See medwatch 8041154-2022-00034.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 an event with j&j band aid brand cushion care sports strips.Consumer stated that she had an allergic reaction that caused burning skin.The consumer started using the product around (b)(6) 2022 (exact dates are unknown) and applied two band aids.The consumer began having symptoms around the same time as usage and the symptoms improved after the consumer stopped using the product.The consumer sought medical attention and was admitted to the hospital and mupirocin ointment and a gauze pad with tape was administered for the treatment.Upon review and based on available information, event resulted with health care professional consult and hospital admission was reported, but no details provided.Patient received mupirocin ointment as treatment and event resolved.This is one of two medwatches being submitted as two devices were involved in this event.See medwatch 8041154-2022-00034.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 february 16, 2019.If information is obtained that was not available for the follow-up #01 medwatch, an additional follow- up medwatch will be filed as appropriate.

• Brand Name: J&J BAND AID BRAND CUSHION CARE SPORTS STRIP
• 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: 15797353
• MDR Text Key: 303639206
• Report Number: 8041154-2022-00033
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370047230
• UDI-Public: (01)381370047230(10)0479B
• 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: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381370047230
• Device Lot Number: 0479B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2019
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female