Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASO LLC; ADHESIVE BANDAGES 10CT
  • 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
 

ASO LLC; ADHESIVE BANDAGES 10CT Back to Search Results
Device Problems Failure to Obtain Sample (2533); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Local Reaction (2035); Skin Irritation (2076)
Event Date 02/23/2018
Event Type  Injury  
Manufacturer Narrative
As of 03/27/2018 aso was unable to confirm the lot# and product subject of this complaint.While every attempt is made to develop a product that meets all users' needs, there is always a possibility that some consumers may be sensitive to certain adhesives, materials, foods and medicines that can potentially cause irritation to the skin.
 
Event Description
Consumer reported that she had an allergic reaction after using one bandage.Consumer reported that she doesn't have available package of the product.She has discarded the primary package months ago.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
ADHESIVE BANDAGES 10CT
Manufacturer (Section D)
ASO LLC
300 sarasota center blvd.
sarasota FL 34240
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 Key7381708
MDR Text Key103828822
Report Number1038758-2018-00011
Device Sequence Number1
Product Code KGX
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 Other
Type of Report Initial
Report Date 03/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/04/2018
Initial Date FDA Received03/29/2018
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-