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

Model Number 381370048336

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

Patient Problems Rash (2033); Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

A male consumer of unknown age reported he used bab tough strips waterproof 20s on his thumb and he accidently rubbed his eyelids and bits of the band-aid and adhesive remained on his eyelids.It was also reported that, the adhesive part of the band-aid was very sticky and leave spots on the skin.Consumer sought medical intervention from an eye doctor who removed the adhesive with tweezers.This is all the known information at this time.

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.A5: patient identifier, age, weight, and ethnicity and race were not provided for reporting.D4: this report is for one (1) bab tough strips waterproof 20s usa 381370048336 8137004833usa 8137004833usa lot/ctrl # 0953b.D4: udi #: (b)(4).Upc #: 381370048336 expiration date: na.Lot #: 0953b d9: 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.A review of the device history records has been requested.H6: health effect clinical code: e1714 also refers to consumer alleged about & quot; spots on skin / rash & quot;.E2008 also refers to consumer alleged about & quot; adhesive was accidentally put into eye lids and adhesive got attached to eyelid & quot;.E2402 refers to consumer " adhesive has been accidentally put into eye lids and got attached to eyelid (accidental exposure & quot;.This event is being submitted as an overabundance of caution.The consumer went to the eye doctor and the doctor removed ¿bits of band aid/ adhesive with tweezers¿ which was not considered significant.No report of any surgical/invasive intervention nor any report of any associated significant injury to eye.No report of any visual impairment.If information is obtained that was not available for the initial medwatch, a 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.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 april 05, 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 TOUGH STRIPS WATERPROOF
• 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: 18484269
• MDR Text Key: 332558221
• Report Number: 8041154-2024-00001
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370048336
• UDI-Public: (01)381370048336(10)0953B
• 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: 01/24/2024

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: 381370048336
• Device Lot Number: 0953B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2023
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male