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

Model Number UPC#681131006729

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

Patient Problems Skin Irritation (2076); Burning Sensation (2146)

Event Date 04/03/2019

Event Type  Injury  

Manufacturer Narrative

The initial complaint by the customer did not indicate that an mdr would be required.4/1/2020 based on a second review of the complaint and information received, aso opted to file an mdr.As of 04/01/2020 aso have not received lot number information or returned samples from the consumer, therefore unable to perform testing.Aso reviewed records of biocompatibility tests and latex screening for similar products.

Event Description

On the initial report on (b)(6) 2019 consumer reported the product caused a burn like reaction to her skin.On email received by our insurance company on 09/03/2019 we were informed that medical attention have been sought by consumer.

• Brand Name: EQUATE
• Type of Device: FLEXIBLE FABRIC ANTIBACTERIAL BANDAGES
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd.; sarasota, fl
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd.; sarasota, fl
• Manufacturer Contact: federico juliao ; 300 sarasota center blvd.; sarasota, fl
• MDR Report Key: 9913572
• MDR Text Key: 187381571
• Report Number: 1038758-2020-00015
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UPC#681131006729
• Device Catalogue Number: 568273937
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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