MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID PLASTIC COMFORT FLEX BANDAGES; TAPE AND BANDAGE, ADHESIVE

Model Number 62600061805

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

Patient Problems Itching Sensation (1943); Pain (1994); Local Reaction (2035); Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)

Event Date 09/02/2022

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.Age at time of event, weight, and ethnicity and race were not provided for reporting.This report is for one band-aid plastic comfort flex assort 80s can 62600061805 6260006180caa 6260006180caa.Device is not distributed in the united states but is similar to device marketed in the usa (bab sheer comfort flex assorted 80s usa 381370046691 8137004669usc 8137004669usc).Lot number is not available.Udi: (b)(4), upc: 62600061805, expiration date: na, lot number: 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 the lot number.This is two of two medwatches being submitted as two devices were involved in this event.See medwatch 8041154-2022-00028.The same patient is represented in each medwatch.If information is obtained that was not available for the initial med-watch, an additional follow-up med-watch will be filed as appropriate.

Event Description

This event involved a female consumer using band-aid plastic comfort flex assorted bandages.On (b)(6) 2022, the consumer used a band-aid plastic comfort flex assorted bandage to cover a small cut on the inside of her left ankle.She used the bandages twice a day and used 2 bandages in total.Within 12 hours after the application, the consumer was experiencing painful itching.She removed the bandage and noticed the gauze of the bandage irritated her skin leaving a red rectangle.The consumer reported the burning and itching became so severe she needed a prescription cream.On unspecified date, the consumer consulted a healthcare professional, who prescribed an antibiotic cream.The consumer did not provide any further details regarding the treatment.On an unspecified day in (b)(6) 2022, she had recovered.The consumer did not have any medical conditions or relevant medical history.This is two of two medwatches being submitted as two devices were involved in this event.See medwatch 8041154-2022-00028.The same patient is represented in each medwatch.

• Brand Name: BAND AID PLASTIC COMFORT FLEX BANDAGES
• 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: 15743556
• MDR Text Key: 303155566
• Report Number: 8041154-2022-00029
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 62600061805
• UDI-Public: (01)62600061805
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 62600061805
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female