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

Model Number 381370044246

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

Patient Problems Urticaria (2278); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Consumer reported an event with band aid bandages extra large tough strips.It was reported that the consumer applied the bandages after a biopsy on warts.Consumer alleged a pretty violent reaction to the product.The adhesive apparently really irritated her skin, got a bright red rash breaking out in hives on top of the rash or as part of the rash.Consumer visited health care professional (hcp) and was given unknown medicine for treatment.Consumer is no longer experiencing any symptoms.This is three of three medwatches being submitted as three devices were involved in this event.See medwatch 8041154-2023-00009 & 8041154-2023-00010.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.A2: patient age at time of event was 85; dec 1937 was provided but exact date not given.A3, a4, a5: patient gender, weight and ethnicity and race were not provided for reporting.D1, d2, d3, d4: this report is for bab tough strips extra large 10s usa 381370044246 8137004424usa 8137004424usa lot/ctrl # 2282b.D4: udi# (b)(4), upc#: 381370044246, lot#: 2282b, expiration date: na.D10: device is not expected to be returned for manufacturer review/investigation.H3, h4, h6: a review of the device history records has been requested.H6: health effect clinical codes: e172006 also refers to consumer alleged about "hives subsumed red rash and irritation".E2402 refers to consumer "intentional misuse/off-label use" of the product.This is three of three medwatches being submitted as three devices were involved in this event.See medwatch 8041154-2023-00009 & 8041154-2023-00010.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.

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 june 18, 2022.Raw material and component records were reviewed and were found acceptable.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This is three of three medwatch follow-ups being submitted as three devices were involved in this event.See medwatch 8041154-2023-00009 & 8041154-2023-00010.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 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: 17037791
• MDR Text Key: 316390718
• Report Number: 8041154-2023-00011
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370044246
• UDI-Public: (01)381370044246(10)2282B
• 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: 06/14/2023

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: 381370044246
• Device Lot Number: 2282B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: 06/14/2023
• Supplement Dates FDA Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR