MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAB ACTIV FLEX ADVANCED ADHESIVE BANDAGE; DRESSING, WOUND, OCCLUSIVE

Model Number 381370044147

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

Patient Problems Blister (4537); Skin Infection (4544)

Event Date 03/07/2024

Event Type  Injury  

Event Description

A 68-year-old female consumer reported adverse event with band aid active flex advanced adhesive bandages.Consumer reported that she applied two bandages on (b)(6) 2024, one at a time on her toes for two days.Consumer reported that her toe got swollen and her toe became twice as big with blisters and looked infected.Consumer sought medical attention and was treated with anti-biotic (cephalexin).Consumer denied any hospitalization.Consumer¿s symptoms have stayed the same at the time of this reporting.This is one of two medwatches being submitted as two devices were involved in this event.See medwatch 2214133-2024-00016.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: weight, and ethnicity and race were not provided for reporting.D1, d2, d3, d4: this report is for one (bab activ flex advanced adhesive bandages 10ct usa 381370044147 8137004414usc, lot/ctrl # 1904c).D4: udi #: (b)(4).Upc #: 381370044147.Lot #: 1904c.Exp date: na.D9: 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 has been requested.H6: health effect clinical code: e1719 refers to "toe was almost like it's infected/the toe looked infected (swelling subsume).Health effect clinical code: e1703 refers to big blister on toe.This is one of two medwatches being submitted as two devices were involved in this event.See medwatch 2214133-2024-00016.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.H2, h4, h6: the product was manufactured on july 10, 2014 and was beyond the shelf life of jun-2017 at the time of this reporting.Based on the manufacturing sites quality agreement, the site keeps the batch documentation for one year after the shelf life therefore the site doesn't have the batch documentation for the reported lot to conduct investigation.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 2 med-watch follow-ups (bab 01) being submitted as two devices were involved in this event.See medwatch 2214133-2024-00016.The same patient is represented in each medwatch follow-up.

• Brand Name: BAB ACTIV FLEX ADVANCED ADHESIVE BANDAGE
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview road; skillman NJ 08558 9418
• Manufacturer (Section G): COLOPLAST; coloplast hungary kft; h-4300 nyirbator; coloplast u.2 ; HU
• Manufacturer Contact: michael connaughton ; 199 grandview rd; skillman, NJ 08558-9418 ; 9086555919
• MDR Report Key: 18980490
• MDR Text Key: 338623675
• Report Number: 2214133-2024-00015
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 381370044147
• UDI-Public: (01)381370044147(10)1904C
• 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: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381370044147
• Device Lot Number: 1904C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female