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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EUROMED, INC. CORE VALUES SMART-HEAL HYDROCOLLOID GEL BANDAGES

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EUROMED, INC. CORE VALUES SMART-HEAL HYDROCOLLOID GEL BANDAGES Back to Search Results
Model Number UPC#017276235326
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Burning Sensation (2146)
Event Date 06/14/2022
Event Type  Injury  
Event Description
On the initial report on 06/14/2022 consumer stated that product caused a reaction similar to chemical burns. Consumer stated sought medical attention with her dermatologist due to the issue.
 
Manufacturer Narrative
As of 07/08/2022 no lot or returned product were provided therefore manufacturer is unable to perform an investigation. Aso reviewed records of biocompatibility tests with no issues noted.
 
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Brand NameCORE VALUES
Type of DeviceSMART-HEAL HYDROCOLLOID GEL BANDAGES
Manufacturer (Section D)
EUROMED, INC.
25 corporate drive
orangeburg NY 10962
Manufacturer (Section G)
ASO LLC
300 sarasota center blvd.
sarasota FL 34240
Manufacturer Contact
aso complaiints
300 sarasota center blvd.
sarasota, FL 34240
MDR Report Key15008736
MDR Text Key295861103
Report Number1038758-2022-00028
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,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model NumberUPC#017276235326
Device Catalogue Number017276235326
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received06/14/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/13/2022 Patient Sequence Number: 1
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