MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND-AID PLUS NEOSPORIN EXTRA LARGE; ADHESIVE BANDAGE

Model Number 381370055679

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

Patient Problems Pain (1994); Rash (2033); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient¿s date of birth, patient¿s weight, ethnicity and race were not provided for reporting.Band-aid plus neosporin extra large (bacitracin zinc, polymyxin b sulfate) (unknown).This report is for one bab antibiotic extra large 8s usa 381370055679 8137005567usb.- combination product.Udi number: (b)(4); lot number: ni; exp date: ni.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 could not be completed without lot number.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 a band aid antibiotic extra large bandage.Consumer used the bandage on biopsy wound and one day after use alleges that she developed swelling, a raised rash and had pain.Consumer sought medical attention and a health care provider applied and unknown cream form treatment.The consumer¿s symptoms have resolved.This report is a non-serious adverse event for drug component (bacitracin zinc/polymyxin b sulfate).The device component (band-aid plus neosporin extra large) is assessed as a reportable event due to medical intervention treatment from health care professional.

• Brand Name: BAND-AID PLUS NEOSPORIN EXTRA LARGE
• Type of Device: ADHESIVE BANDAGE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview road; 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: 10087976
• MDR Text Key: 194803714
• Report Number: 8041154-2020-00014
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370055679
• UDI-Public: (01)381370055679
• Combination Product (y/n): Y
• PMA/PMN Number: K954007
• 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: 05/02/2020

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: 381370055679
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/02/2020
• Initial Date FDA Received: 05/26/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention