MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAB FLEXIBLE FABRIC BANDAGES; TAPE AND BANDAGE, ADHESIVE

Model Number 81370044444

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

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

Event Date 01/06/2024

Event Type  Injury  

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.Patient age, weight, ethnicity and race were not provided for reporting.D4: bab flexible fabric 1in 100s usa (b)(4) usa, lot number 220417.D4: udi #(b)(4).Upc # (b)(4).Lot #220417 expiration date: na.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: e2402 refers to consumer "intentional misuse/off-label use" of the product.This event is being reported as an over abundance of caution.At this time, there is no indication of any significant medical treatment or intervention; however, consumer labeled the event as a serious injury if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A voluntary fda medwatch, mw5150586, was received reporting an event with band-aid flexible fabric bandage.A male consumer reported the following: had skin cancer taken off.Wound care was cover it with a bandage.Used band-aid flexible fabric bandage and developed a skin rash.Was back at the dermatologist for follow up and discussed adhesive allergies.Consumer labeled the incident as a serious injury.

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: 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 17, 2022.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 FLEXIBLE FABRIC 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): SHANGHAI, CHIN; 120 nan ya road; minghang, shanghai 20024 5; CH 200245
• Manufacturer Contact: michael connaughton ; 199 grandview rd; skillman, NJ 08558-9418 ; 9086555919
• MDR Report Key: 18763551
• MDR Text Key: 336054803
• Report Number: 1000599868-2024-00002
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

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: 81370044444
• Device Lot Number: 220417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male