MAUDE Adverse Event Report: JOHNSON & JOHNSON INC BAND AID BRAND BANDAGES WATERBLOCK FLEX BANDAGES; TAPE AND BANDAGE, ADHESIVE

Model Number 381371190621

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

Patient Problems Rash (2033); Impaired Healing (2378); Skin Infection (4544)

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.A4, a5: patient weight, and ethnicity and race were not provided for reporting.B3: event start date: (b)(6) 2023.D1, d2, d3, d4: this report is for one (1) band aid brand bandages waterblock flex adhesive cover 6ct (b)(4) usa, lot number 0313b.D4: udi #: (b)(4), upc # (b)(4), lot number #: 0313b, expiration date: na.D10: device is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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.H6: health effect clinical code: e1714 also refers to consumer alleged about rashes ran down the wound area and rash got so bad;.E1719 also refers to consumer alleged about second-degree infection on skin.E1707 also refers to consumer about wound got enlarged and worse.This medwatch is for lot number-0313b.Three med watches (8041154-2023-00021 & 8041154-2023-00022) are being submitted as consumer reported use of three different boxes of band-aids with the same event description.See medwatch 8041154-2023-00021 & 8041154-2023-00022.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.

Event Description

A female consumer reported and event with band aid brand bandages waterblock flex adhesive cover.Consumer had a minor wrist injury made injury worse because there was no air at all once she put on the product.She developed a lot of rashes that ran down the wound area, and the wound got enlarged.The rash got so bad, it gave her a second-degree infection.The sticky area got rashes.The symptoms have remained the same.Consumer went to hospital to clean up the wound and was advised to immediately stop using the bandage she was discharged on the same day (b)(6) 2023.The consumer was also advised by the doctor that they used collagen powder to treat the wound.This medwatch is for lot number-0313b.Three med watches (8041154-2023-00021 & 8041154-2023-00022) are being submitted as consumer reported use of three different boxes of band-aids with the same event description.See medwatch 8041154-2023-00021 & 8041154-2023-00022.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 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 january 31, 2023.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 BANDAGES WATERBLOCK FLEX BANDAGES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON 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: michael connaughton ; 199 grandview rd; skillman, NJ 08558-9418 ; 9086555919
• MDR Report Key: 17700180
• MDR Text Key: 322857542
• Report Number: 8041154-2023-00020
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381371190621
• UDI-Public: (01)381371190621(10)0313B
• 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,Followup
• Report Date: 09/18/2023

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: 381371190621
• Device Lot Number: 0313B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 09/18/2023
• Supplement Dates FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2023
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female