MAUDE Adverse Event Report: ASO LLC TARGET; FABRIC ANTIBACTERIAL BANDAGE XL

Model Number UPC017276226256

Device Problems Failure to Obtain Sample (2533); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Irritation (1941)

Event Date 05/03/2016

Event Type  Injury  

Manufacturer Narrative

As of 05/31/2016 aso has not received further information regarding a lot number.However, aso has reviewed records of biocompatibility test for materials used to manufacture the same type of products.Aso will follow up on this report as soon as we receive further information from the consumer.

Event Description

Consumer reported that she had an allergic reaction on her left hand and both eyes.Consumer stated that she is allergic to certain tape but she did not see any information on the box.Consumer sought medical attention and the doctor in the emergency room could not find any information on the contents of the product.

Manufacturer Narrative

As of 05/31/2016 aso has not received further information regarding a lot number.However, aso has reviewed records of biocompatibility test for materials used to manufacture the same type of products.Aso will follow up on this report as soon as we receive further information from the consumer.On 06/06/16 aso received unused returned samples from consumer and performed testing for adhesion properties.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 on her left hand and both eyes.Consumer stated that she is allergic to certain tape but she did not see any information on the box.Consumer sought medical attention and the doctor in the emergency room could not find any information on the contents of the product.

• Brand Name: TARGET
• Type of Device: FABRIC ANTIBACTERIAL BANDAGE XL
• 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: 5689091
• MDR Text Key: 46219979
• Report Number: 1038758-2016-00075
• 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,Followup
• Report Date: 06/06/2016

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 Expiration Date: 12/10/2020
• Device Model Number: UPC017276226256
• Device Catalogue Number: 245070727
• Device Lot Number: 39974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/03/2016
• Initial Date FDA Received: 05/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2015
• 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
• Patient Age: 43 YR
• Patient Weight: 85