MAUDE Adverse Event Report: ASO LLC TARGET; SHEER ANTIBACTERIAL ADHESIVE BANDAGE 3X4

Model Number UPC017276226355

Device Problem Failure to Obtain Sample (2533)

Patient Problems Rash (2033); Skin Irritation (2076)

Event Date 01/05/2016

Event Type  Injury  

Manufacturer Narrative

Aso was unable to evaluate samples because the consumer has not responded with additional information including their identity.Aso has evaluated reports of biocompatibility tests performed on materials used to manufacture the same product.Consumer not responding to provide info.

Event Description

Consumer used device and the adhesive caused an allergic reaction, itching, burning and rash.

• Brand Name: TARGET
• Type of Device: SHEER ANTIBACTERIAL ADHESIVE BANDAGE 3X4
• 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 ; 9413790300
• MDR Report Key: 5413951
• MDR Text Key: 37591077
• Report Number: 1038758-2016-00009
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2016

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
• Device Model Number: UPC017276226355
• Device Catalogue Number: 245070726
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/08/2016
• Initial Date FDA Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1