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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EUROMED, INC. CVS HEALTH HYDROCOLLOID BLISTER CARE CUSHIONS

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EUROMED, INC. CVS HEALTH HYDROCOLLOID BLISTER CARE CUSHIONS Back to Search Results
Model Number UPC#050428253212
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Abrasion (1689)
Event Date 05/20/2019
Event Type  Injury  
Manufacturer Narrative
As of 06/03/2019 aso could not confirm the lot number for additional investigation. Satisfactory biocompatibility test results for the materials used to manufacture the same type of products were reviewed. Refer to b. 6 for further details. Complaint database was reviewed; there was no negative trend identified for the associated product.
 
Event Description
Consumer stated that product was stuck completely to wound. Consumer reported that she went to the urgent care for assistance and it was excruciatingly painful. She received prescription antibacterial cream and nonstick gauze.
 
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Brand NameCVS HEALTH
Type of DeviceHYDROCOLLOID BLISTER CARE CUSHIONS
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
federico juliao
300 sarasota center blvd.
sarasota, FL 34240
MDR Report Key8711897
MDR Text Key148416280
Report Number1038758-2019-00016
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 company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 05/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUPC#050428253212
Device Catalogue Number262332
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 06/19/2019 Patient Sequence Number: 1
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