MAUDE Adverse Event Report: ASO LLC EQUATE; HEAVY DUTY FABRIC BANDAGES ANTIBACTERIAL

Model Number UPC#681131068376

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

Patient Problems Irritation (1941); Rash (2033)

Event Date 10/13/2016

Event Type  Injury  

Manufacturer Narrative

The initial complaint by the customer did not indicate that an mdr would be required.However, per the info received on 08/21/2019 medical treatment was sought.Based on the information received, aso opted to file an mdr.As of 10/22/2019 no response or returned samples have been received from consumer.Unused retained samples of the same lot as the product reported were submitted to the lab for testing with no defects noted.In addition, aso reviewed records of biocompatibility tests with no issues noted.

Event Description

On the initial report of (b)(6) 2016 consumer stated that product caused a rash on whenever the skin came in contact with the tape area, but no indication that medical attention was sought.On 08/21/2019 aso became aware that the patient sought medical attention.

• Brand Name: EQUATE
• Type of Device: HEAVY DUTY FABRIC BANDAGES ANTIBACTERIAL
• 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 Key: 9252233
• MDR Text Key: 164828372
• Report Number: 1038758-2019-00049
• 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: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/13/2021
• Device Model Number: UPC#681131068376
• Device Catalogue Number: 552173655
• Device Lot Number: 00050677
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2016
• 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 Outcome(s): Other