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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EUROMED, INC. CVSPHARMACY ADVANCED HEALING PREMIUM BANDAGES

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EUROMED, INC. CVSPHARMACY ADVANCED HEALING PREMIUM BANDAGES Back to Search Results
Model Number UPC#050428171240
Device Problems Failure to Obtain Sample (2533); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Abrasion (1689)
Event Date 09/03/2018
Event Type  Injury  
Manufacturer Narrative
Aso has reviewed records of biocompatibility tests as well as manufacturer's tests with no issues reported. Manufacturer stated that there is no evidence of a trend associated with the bandages that would indicate an increased risk to user safety. Aso complaint database was reviewed; there was no (b)(6) trend identified for the associated product. Refer this report for further details.
 
Event Description
The initial report on (b)(6) 2018 consumer informed that product was used to cover burn. Customer stated that she feels that burn may have got worse after using the product. Consumer stated that she has removed bandage and product ripped her skin around burn area. Costumer requested composition of bandage. The completed customer information request (cir) was received on 09/24/2018. Consumer stated that she removed bandage within the first day as the bandage did not seal properly. Customer required medical treatment and the symptoms did not correct after she stopped using the product. Her doctor prescribed a burn ointment and antibiotics.
 
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Brand NameCVSPHARMACY
Type of DeviceADVANCED HEALING PREMIUM 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
federico juliao
300 sarasota center blvd.
sarasota, FL 34240
MDR Report Key7954248
MDR Text Key123359230
Report Number1038758-2018-00028
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 company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 09/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/07/2017
Device Model NumberUPC#050428171240
Device Catalogue Number371579
Device Lot Number00007247
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/08/2014
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/10/2018 Patient Sequence Number: 1
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