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

Model Number UPC#681131006736

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Skin Irritation (2076)

Event Date 01/15/2020

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 (b)(6) 2020 consumer stated medical treatment was sought.Based on the information received, aso opted to file an mdr.As of 03/05/2020 unused retained samples of the same lot as the product reported and returned product were submitted to the lab for testing with no defects noted.In addition, aso reviewed records of biocompatibility tests with no issues noted.Refer to this report for further details.

Event Description

On the initial report of 01/15/2020 consumer stated that the adhesive part of the product caused him red mark and irritation on his abdominal skin.On email received on (b)(6) 2020 consumer stated 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
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd.; sarasota, fl
• Manufacturer Contact: federico juliao ; 300 sarasota center blvd.; sarasota, fl
• MDR Report Key: 9802295
• MDR Text Key: 182472886
• Report Number: 1038758-2020-00010
• 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: 02/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UPC#681131006736
• Device Catalogue Number: 566928026
• Device Lot Number: 00116601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2019
• 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
• Patient Age: 76 YR