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 Problems Pain (1994); Skin Irritation (2076); Burning Sensation (2146)

Event Date 01/05/2016

Event Type  Injury  

Manufacturer Narrative

Aso has not received a lot number or returned samples from consumer as of 03/31/2016.Aso is unable to perform evaluation for adhesion properties because no information is available.However, aso reviewed records of biocompatibility tests for materials used to manufacture the same type of products.Aso will monitor complaint database for any trends on adverse events on this product.Consumer did not provide lot or samples.

Event Description

Consumer stated they used bandage for a cut and this caused a severe allergic reaction causing itching, burning and a rash due to the adhesive.Consumer was given topical medication/antibiotics to clear the rash.

Manufacturer Narrative

Aso has not received a lot number or returned samples from consumer as of 03/31/2016.Aso is unable to perform evaluation for adhesion properties because no information is available.However, aso reviewed records of biocompatibility tests for materials used to manufacture the same type of products.Aso will monitor complaint database for any trends on adverse events on this product.Aso received returned samples of the product and noticed that the device originally reported did not correspond with the samples returned by the consumer.Aso evaluated the returned samples as well as retained samples of the same lot number for adhesion properties on 05/11/16.

Event Description

Consumer stated they used bandage for a cut and this caused a severe allergic reaction causing itching, burning and a rash due to the adhesive.Consumer was given topical medication/antibiotics to clear the rash.

• 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: 5540055
• MDR Text Key: 41612272
• Report Number: 1038758-2016-00047
• 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: 05/09/2016

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: 178519
• Device Lot Number: 39974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2016
• Initial Date FDA Received: 03/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: No
• 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