MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC. BAB FAMILY VARIETY PACK USA BAFMVPUS; TAPE AND BANDAGE, ADHESIVE

Model Number 381371190577

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

Patient Problems Skin Tears (2516); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/20/2024

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, ethnicity and race were not provided for reporting.D1, d2, d3, d4: this report is for one (1) band aid brand bandages variety assorted 30ct usa 381371190577 381371190577usa 381371190577usa lot/ctrl # 2193b.D4: udi (b)(4).Upc #381371190577.Expiration date: na.Lot # 2193b.D9: 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: e1721 also refers to consumer alleged about "removed 4 inch,2 layers of skin, bleeding subsumed described as like 3rd degree burns".E2402 refers to consumer "intentional misuse/off-label use" of the product.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A 74-year-old female consumer reported applying a bandage from a band-aid brand variety bandage box to a small scratch that was almost completely healed.Consumer reported that while trying to remove the product, it removed layers of skin and bled profusely.The consumer reported that it was like a third-degree burn.The symptoms improved after the patient stopped using the product.The consumer sought medical intervention with physician and was treated with an application of an unspecified cream and antibiotics.

Event Description

Updated information received on 08-feb-2024 that the patient is no longer experiencing any symptoms.

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.H2,h4, h6: device history records review for the bab family variety pack usa was completed.As the patient only used one tough strip in the bab family variety pack usa, the manufacturing records review of the semi-finished tough strip packed into the variety pack were completed.No non-conformance reports were generated during production.Review of the device history records and semi-finished tough strip manufacturing 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 07, 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: BAB FAMILY VARIETY PACK USA BAFMVPUS
• 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: michael connaughton ; 199 grandview rd; skillman, NJ 08558-9418 ; 9086555919
• MDR Report Key: 18763766
• MDR Text Key: 336050401
• Report Number: 8041154-2024-00002
• Device Sequence Number: 1
• Product Code: KGX
• 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: 02/08/2024

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: 381371190577
• Device Lot Number: 2193B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 02/08/2024
• Supplement Dates FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female