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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND HYDROSEAL BANDAGES LARGE DRESSING, WOUND, OCCLUSIVE Back to Search Results
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.
 
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Brand NameBAND AID BRAND HYDROSEAL BANDAGES LARGE
Type of DeviceDRESSING, 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 Key14654349
MDR Text Key293717731
Report Number2214133-2022-00025
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
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 Received06/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number381371174010
Device Lot Number0981C
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Date Manufacturer Received08/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/09/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/10/2022 Patient Sequence Number: 1
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