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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EUROMED, INC. TOPCARE ADVANCED HEALING HYDROCOLLOID BANDAGES

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EUROMED, INC. TOPCARE ADVANCED HEALING HYDROCOLLOID BANDAGES Back to Search Results
Model Number UPC#036800103863
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Abrasion (1689)
Event Type  Injury  
Manufacturer Narrative
As of 09/06/2019 manufacturer evaluated retained product samples with no defects noted. In addition, aso reviewed records of biocompatibility tests. Refer to section b. 6 of this report for further details.
 
Event Description
On the initial report on (b)(6) 2019 reporter informed the dressing got stuck and tore the medical glue placed on her incisions after surgery. On cir received on (b)(6) 2019 reporter stated that sought medical attention, and a new bandage was placed on the affected area by the physician.
 
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Brand NameTOPCARE
Type of DeviceADVANCED HEALING HYDROCOLLOID 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 Key8984305
MDR Text Key161608360
Report Number1038758-2019-00033
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 07/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUPC#036800103863
Device Catalogue Number003680010386
Device Lot Number00090917
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/30/2018
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: 09/10/2019 Patient Sequence Number: 1
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