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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EUROMED, INC. CVS HEALTH ADVANCED HEALING HYDROCOLLOID PADS

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EUROMED, INC. CVS HEALTH ADVANCED HEALING HYDROCOLLOID PADS Back to Search Results
Model Number UPC#050428397930
Device Problem Off-Label Use (1494)
Patient Problem Abrasion (1689)
Event Type  Injury  
Manufacturer Narrative
As of (b)(6) 2019 manufacturer evaluated retained product samples with no defects noted. In addition, aso reviewed records of biocompatibility tests.
 
Event Description
On the initial report on (b)(6) 2019 consumer reported the damaged situation from procedure on (b)(6) 2019 reporter stated on returned cir that the product tore her stitches and she went to emergency room to get stitches reapplied.
 
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Brand NameCVS HEALTH
Type of DeviceADVANCED HEALING HYDROCOLLOID PADS
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 Key9031894
MDR Text Key161170167
Report Number1038758-2019-00035
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 07/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUPC#050428397930
Device Catalogue Number0893118
Device Lot Number00096866
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/08/2019
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: 09/13/2019 Patient Sequence Number: 1
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