MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC. BAND AID TOUGH STRIP WATERPROOF BANDAGES; TAPE AND BANDAGE, ADHESIVE

Model Number 062600061591

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

Patient Problems Pain (1994); Local Reaction (2035)

Event Type  Injury  

Event Description

This event involves a consumer of unspecified age and gender using band-aid tough strip waterproof bandages (20 count) (lot not reported).The consumer stated, via social media, your latex [labeling] should be bigger and thought it didn¿t have latex because i was looking for latex in bold or black writing.So because i didn¿t see it, i used it and i had a big reaction to it and was on iv antibiotics for over a week.The pain was unbearable at times.I was almost admitted to a hospital "iv antibiotics was interpreted as intravenous route; setting not specified.No further details were provided.The incident date, product usage details, and medical history are unknown.

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.A1, a2, a3, a4, a5: patient information was not provided for reporting.Name provided in section e was social media handle.D1, d2, d3, d4: this report is for one (1) band-aid tough strip waterproof 20s can 062600061591 6260006159caa 6260006159caa.Device is not distributed in the united states, but is similar to device marketed in the usa (bab tough strips waterproof 20s usa 381370048336 8137004833usa).Lot number was not available for reporting.D4: udi # (b)(4).Upc # 062600061591.Expiration date: na.Lot #ni.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.Device history records review could not be completed without lot number.The product label for band-aid tough strip waterproof bandages (20 count) has the following statement regarding latex: "not made with natural rubber latex." h6: health effect clinical code: e040203 - refers to consumer alleged "big reaction on skin." 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 TOUGH STRIP WATERPROOF BANDAGES
• 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: 18143762
• MDR Text Key: 328201584
• Report Number: 8041154-2023-00028
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 062600061591
• UDI-Public: (01)062600061591(10)NI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2023

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: 062600061591
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/15/2023
• 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