MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND HYDROSEAL BANDAGES LARGE; DRESSING, WOUND, OCCLUSIVE

Model Number 381371174010

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

Patient Problems Scar Tissue (2060); Skin Tears (2516); Caustic/Chemical Burns (2549); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/14/2022

Event Type  Injury  

Event Description

A female consumer reported an event with a band aid brand hydroseal bandages large 6 ct.Consumer applied hydroseal large band aid on (b)(6) 2022 on a pimple on the breast.Consumer alleges that she started feeling burning sensation 2 hours after she put the band aid on.Consumer stated that adhesive was stuck, and she could not remove the product, so she took a shower and was able to remove the product.The consumer alleges that the product peeled off her skin and made her skin gummy.Consumer sought medical attention and doctor confirmed that it is a chemical burn.An ointment and antibiotics were provided as a treatment.Consumer is still not recovered at time of reporting.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient¿s date of birth, patient¿s weight, ethnicity and race were not provided for reporting.This report is for one band aid brand hydroseal bandages large 6ct usa.Udi number: (b)(4).Upc #: 381371174010; lot number: 0981c; 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 9, 2021.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Consumer letter and medical records dated on (b)(6) 2022 were received and reviewed.It was reported by the consumer that she tried to peel the band-aid off because of burning and hurting.According to medical records, consumer sought medical attention on (b)(6) 2022 for an ointment burn that has not gone away nor gotten better with the antibiotics.Her doctor opined that it looks like minimal chemical burn on the right breast.The doctor recommended no more band-aids or topical creams, and to finish doxycycline and follow up as scheduled if symptoms do not resolve.On (b)(6) 2022, the consumer had a follow up with doctor and recommendations were to use the mupirocin and if not continuing to improve, take cephalexin.Consumer also reported that her skin finally healed, however, she still has scars where she tried to take the band-aid off and skin layers were ripped off.

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.Additional data: a2 - patient age and patient date of birth.A4 - patient weight.B5 - updated reporter verbatim.B7- updated consumer's height and allergy information.H6: health effect clinical code e170401: subsumed symptoms burning sensation and hurt.If information is obtained that was not available for the follow-up (01) medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BAND AID BRAND HYDROSEAL BANDAGES LARGE
• 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: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 14654349
• MDR Text Key: 293717731
• Report Number: 2214133-2022-00025
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 381371174010
• UDI-Public: (01)381371174010(10)0981C
• 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: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381371174010
• Device Lot Number: 0981C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 100 KG