• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EUROMED, INC. KROGER ADVANCED ACTIVE HEALING BLISTER BANDAGE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

EUROMED, INC. KROGER ADVANCED ACTIVE HEALING BLISTER BANDAGE Back to Search Results
Model Number UPC#041260373114
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Abrasion (1689)
Event Date 01/22/2018
Event Type  Injury  
Manufacturer Narrative
The initial complaint by the customer did not indicate that an mdr would be required. However, the consumer stated on 02/20/2018 that she required treatment. Based on the information received, aso opted to file an mdr. Aso has reviewed records of biocompatibility tests as well as manufacturer's tests with no issues reported. In addition, the bandage is an adhesive bandage which is intended to stick and its adhesion level is at its highest when it is first placed on the skin. As noted by the customer, she tried to remove the bandage within an hour of application in a forceful manner.
 
Event Description
The initial report on 02/01/2018 consumer stated that product pulled her skin off. No medical attention was sought. However, on 02/20/2018 the consumer sent a follow up report indicating that she required treatment.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameKROGER
Type of DeviceADVANCED ACTIVE HEALING BLISTER BANDAGE
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 Key7338127
MDR Text Key102365305
Report Number1038758-2018-00006
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 02/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/05/2022
Device Model NumberUPC#041260373114
Device Catalogue Number01196
Device Lot Number00067746
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/06/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-