MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAB BLISTER GEL GUARD FOR HEELS / ADV PROTECT BLISTER / HEAL; DRESSING, WOUND, OCCLUSIVE

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

Patient Problems Local Reaction (2035); Contact Dermatitis (4546); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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.A4, a5: patient weight, and ethnicity and race were not provided for reporting.B3: june 2023.D1, d2, d3, d4: this report is for one (1) band-aid blister gel guard for heels / adv protect blister / heal unspecified usa notapplicable baadhlusunsp baadhlusunsp , lot number ni.D4: udi, upc, lot number and expiration date are not available.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 could not be completed without lot number.H6: health effect clinical code: e040203 also refers to consumer alleged about ¿noticed some area where the adhesive from bandage stuck to skin/went into her pores¿ e172003 also refers to consumer alleged about ¿dermatitis subsumed skin that are red and outline of the patches on face¿.E2402 refers to consumer intentional misuse/off-label use of the product.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A 50 year old female consumer reported on event on 07-nov-2023.The consumer stated that she started using band-aid blister gel guard for heels to cover acne on face since 2022 and that she was pleased with how they worked.Consumer experienced symptoms in (b)(6) 2023.She noticed the outline of patches on her face and some patches were red.Consumer reported that she put patches on her eyebrows and in hairline, and it looks like eyebrows are thinning.Consumer also noticed some areas where the adhesive from bandage stuck to her skin and went into her skin pores.Consumer visited a dermatologist and physician.As consumer reported, doctors opined that it is dermatitis and prescribed her with creams, one of them triamcinolone.Consumer stated that she did not tell doctors about using blister patches on the acne areas.The symptoms did improve after the consumer stopped using the product, but the consumer is still experiencing some symptoms.

• Brand Name: BAB BLISTER GEL GUARD FOR HEELS / ADV PROTECT BLISTER / HEAL
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; 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: 18185087
• MDR Text Key: 328737912
• Report Number: 2214133-2023-00037
• Device Sequence Number: 1
• Product Code: NAD
• 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: 11/07/2023

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
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/21/2023
• 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
• Patient Sex: Female