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 Problem Skin Tears (2516)

Event Date 10/26/2022

Event Type  Injury  

Event Description

Consumer reported an event with band-aid waterproof tough strips.The consumer had a cut on her arm and used the band aid for wound.On (b)(6) 2022, when the consumer tried to pull it off, her skin came right off.It was reported that consumer used one or two bandages each time.The consumer was still experiencing symptoms while reporting this event.Consumer visited urgent care where she was prescribed unknown antibiotics for treatment and stated that she was admitted to the hospital.This is one of two medwatches being submitted as two devices were involved in this event.See medwatch 8041154-2022-00032.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 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.This report is for one (1) bab tough strips waterproof 20s usa 381370048336 8137004833usa 8137004833usa, lot number 0952b.Udi #: (b)(4).Upc #: 381370048336, lot #: 0952b and exp date: na.Device is not expected to be returned for manufacturer review/investigation.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 4, 2012.This is one of two medwatches being submitted as two devices were involved in this event.See medwatch 8041154-2022-00032.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.

• 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: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 15770644
• MDR Text Key: 303410564
• Report Number: 8041154-2022-00031
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370048336
• UDI-Public: (01)381370048336(10)0952B
• 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
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• 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: 0952B
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2012
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female