MAUDE Adverse Event Report: ASO LLC EQUATE; ANTIBACTERIAL FLEXIBLE FABRIC XL BANDAGES

Model Number UPC#681131052931

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

Patient Problem Skin Irritation (2076)

Event Date 12/19/2016

Event Type  Injury  

Manufacturer Narrative

On 2/19/2016 the initial complaint by the customer did not indicated that an mdr would be required.However, the consumer submitted completed customer information request to aso on 01/18/2017 informing that medical attention was sought.Based on the information received, aso opted to file an mdr.Aso has evaluated retained samples of the same lot number.The results are acceptable with no defects found during testing.In addition, aso has reviewed records of biocompatibility tests and latex screening on adhesives.

Event Description

Consumer reported that after using bandage, it caused her sores.Consumer stated that bandage is too strong.

• Brand Name: EQUATE
• Type of Device: ANTIBACTERIAL FLEXIBLE FABRIC XL BANDAGES
• 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: 6333121
• MDR Text Key: 67516188
• Report Number: 1038758-2017-00006
• 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: 12/19/2016

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: 09/21/2021
• Device Model Number: UPC#681131052931
• Device Lot Number: 00053106
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 63