MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC J&J BAND AID BRAND FIRST AID WATERPROOF PADS; TAPE AND BANDAGE, ADHESIVE

Model Number 381371161447

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

Patient Problems Erythema (1840); Pain (1994); Rash (2033); Sleep Dysfunction (2517); Skin Infection (4544)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight, and ethnicity and race were not provided for reporting.Udi #: (b)(4).Upc #: (b)(4).Lot #: 0770b.Expiration date: na.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 mar 17, 2020.This is 1 of 2 med-watches being submitted as two devices were involved in this event.See medwatch 8041154-2021-00008.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 consumer reported an event with j&j band aid brand first aid waterproof pads.Consumer reported that he used two (2) of the large j&j band aid brand first aid waterproof pads to cover a wound.For approximately two weeks the consumer had red and raised area where the adhesive touched the skin.The consumer stated that the products left a rash on his back and the rash contributed to an infection of the area, from which a basil cell tumor was removed on october 31, 2020.The consumer also stated that he lost sleep and had substantial discomfort.Consumer applied neosporin ointment and a vaseline-type product.Consumer visited health care provider and was prescribed two medications for treatment, cefadroxil 50mg & triamcinolone 0.1% cream.This is 1 of 2 med-watches being submitted as two devices were involved in this event.See medwatch 8041154-2021-00008.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.Additional information was received on may 11, 2021 from consumer doctor that, consumer had followed up on april 12, 2021 and doctor had confirmed the application site was well healed for the consumer.H6 health effect - impact code - f28 refers for doctor had confirmed the application site was well healed for the consumer.This is 1 of 2 follow-up med-watches being submitted as two devices were involved in this event.See medwatch 8041154-2021-00008.The same patient is represented in each medwatch.If information is obtained that was not available for the follow-up #1 medwatch, an additional follow-up medwatch will be filed as appropriate.

Event Description

Additional information was received on may 11, 2021 from consumer doctor that, consumer had followed up on april 12, 2021 and doctor had confirmed the application site was well healed for the consumer.This is 1 of 2 follow-up med-watches being submitted as two devices were involved in this event.See medwatch 8041154-2021-00008.The same patient is represented in each medwatch.

• Brand Name: J&J BAND AID BRAND FIRST AID WATERPROOF PADS
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• MDR Report Key: 11472615
• MDR Text Key: 250374825
• Report Number: 8041154-2021-00007
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381371161447
• UDI-Public: (01)381371161447(10)0770B
• 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,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381371161447
• Device Lot Number: 0770B
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 03/12/2021
• Supplement Dates Manufacturer Received: 05/11/2021
• Supplement Dates FDA Received: 05/12/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention