MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND INFECTION DEFENSE LARGE ADHESIVE COVER WITH NEOSPORIN; TAPE AND BANDAGE, ADHESIVE

Model Number 381371192533

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

Patient Problems Laceration(s) (1946); Skin Infection (4544)

Event Date 02/16/2023

Event Type  Injury  

Event Description

A consumer reported an event with band aid brand infection defense large adhesive cover with neosporin.The consumer applied product to cover a cut on her stomach and had a reaction/an infection.The consumer & apos's cut was a pre-existing condition that got worse because of the product usage.It was reported that the symptoms have worsened and was still experiencing the symptoms while reporting this event.The patient visited health care provider for the treatment and was told to use an antibiotic.

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.Age 52 patient weight, and ethnicity and race were not provided for reporting.This report is for one (1) band aid brand infection defense large adhesive cover with neosporin 6ct usa 381371192533 381371192533usa 381371192533usa, lot number 2202b.Udi #: (b)(4), upc #: 381371192533, lot #: 2202b, expiration 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.A review of the device history records has been requested.Health effect clinical code: e2009 - also refer to consumer alleged about "cut got worse".If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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 august 08, 2022.Raw material and component records were reviewed and were found acceptable.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: BAND AID BRAND INFECTION DEFENSE LARGE ADHESIVE COVER WITH NEOSPORIN
• 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: 16553830
• MDR Text Key: 311405716
• Report Number: 8041154-2023-00005
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381371192533
• UDI-Public: (01)381371192533(10)2202B
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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,Followup
• Report Date: 03/29/2023

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: 381371192533
• Device Lot Number: 2202B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 03/29/2023
• Supplement Dates FDA Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female