MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND TRU STAY SHEER BANDAGES / SHEER; TAPE AND BANDAGE, ADHESIVE

Model Number 381370047681

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

Patient Problems Itching Sensation (1943); Rash (2033); Blister (4537); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/05/2022

Event Type  Injury  

Event Description

Consumer reported she used band-aid brand tru stay sheer large adhesive pads to cover a large wound that she had on her left arm.Consumer started using product on (b)(6) 2022 and alleged that on (b)(6) 2022 she broke out in a rash, developed blisters and had itching.The symptoms improved after the patient stopped using the product.Consumer consulted her doctor and was prescribed bactin for the treatment and was told to cover the wound with sterile bandage.The consumer is still experiencing the symptoms but they have improved.This is three of three medwatches being submitted as three devices were involved in this event.See medwatches 8041154-2022-00021, 8041154-2022-00022.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 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) band-aid brand tru stay sheer large adhesive pad 10ct(b)(4), lot number-n/a.D4: udi #: (b)(4).Upc: (b)(4).Lot number: ni.Exp 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.Device history records review could not be completed without lot number.(b)(4).This is three of three medwatches being submitted as two devices were involved in this event.See medwatches 8041154-2022-00021, 8041154-2022-00022 &.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.

• Brand Name: BAND AID BRAND TRU STAY SHEER BANDAGES / SHEER
• 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: 15533420
• MDR Text Key: 301128467
• Report Number: 8041154-2022-00023
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370047681
• UDI-Public: (01)381370047681(10)NI
• 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
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381370047681
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 09/07/2022
• 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: 73 YR
• Patient Sex: Female