MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAB TOUGH STRIPS; TAPE AND BANDAGE, ADHESIVE

Model Number 381371155675

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

Patient Problem Contact Dermatitis (4546)

Event Date 11/11/2023

Event Type  Injury  

Event Description

A 33-year-old male consumer reported an event with band-aid tough strips all one size bandages.Consumer started using bandages on 10-nov-2023 for cuts on legs and elbow.Consumer reported using three band-aids on left leg, one on right leg and one on left elbow.Consumer alleged that on 11-nov-2023, consumer developed large weeping lesions/rash with swelling on legs and elbows from using this products.Consumer went to urgent care on 13-nov-2023 and was told that consumer had cellulitis and was given antibiotics.Consumer was also told by practitioner that left leg is likely to scar due to the severity of the reaction.Consumer went on 16-nov-2023 for a follow-up and it was determined that it was not cellulitis, but it was contact dermatitis, and was given oral steroids (prednisone) for the swelling and a topical ointment for the itch.Consumer is still not recovered at the time of reporting.This is 1 of 5 med-watches (bab 01- left leg) being submitted as five devices were involved in this event.See medwatch 8041154-2023-00030; 8041154-2023-00031; 8041154-2023-00032; 8041154-2023-00033.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.A4, a5: patient, weight, ethnicity and race were not provided for reporting.D4: this report is for one (1) bab tough strips 1x3 1/4 in 60s usa 381371155675 8137115567usa 8137115567usa, lot/ctrl # 3422b d4: udi #: (b)(4).Upc # 381371155675.Lot # 3422b.Expiration date:.D10: device is not expected to be returned for manufacturer review/investigation.H6: device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review has been requested.Health effect clinical code: e172003 refers to consumer alleged for "contact dermatitis- large weeping lesions on legs and elbow, swelling and itch & quot;.This is 1 of 5 med-watches (bab 01- left leg) being submitted as five devices were involved in this event.See medwatch 8041154-2023-00030; 8041154-2023-00031; 8041154-2023-00032; 8041154-2023-00033.The same patient is represented in each medwatch.If information is obtained that was not available for the initial medwatch, an additional 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.H2, 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 december 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.This is 1 of 5 med-watch follow-ups (bab 01- left leg) being submitted as five devices were involved in this event.See medwatch 8041154-2023-00030; 8041154-2023-00031; 8041154-2023-00032; 8041154-2023-00033.The same patient is represented in each medwatch follow-up.

• Brand Name: BAB TOUGH STRIPS
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview road; 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: 18312041
• MDR Text Key: 330293752
• Report Number: 8041154-2023-00029
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381371155675
• UDI-Public: (01)381371155675(10)3422B
• 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: 12/12/2023

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: 381371155675
• Device Lot Number: 3422B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/18/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 12/12/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male