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

Model Number UPC#681131006712

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 11/15/2022

Event Type  Injury  

Manufacturer Narrative

As of (b)(6) 2022 aso has requested the batch record of the affected lot number, including retained samples for further testing.Aso reviewed records of satisfactory biocompatibility tests for this type of product with no issues noted.In addition, complaint database was reviewed and no negative trend has been identified for the associated product.

Event Description

Consumer stated on (b)(6) 2022 that product caused an allergic reaction to her son.The affected area was red inflamed and was advised by the doctor not to use the product.

Event Description

Consumer stated on (b)(6)2022 that product caused an allergic reaction to her son.The affected area was red inflamed and was advised by the doctor not to use the product.Consumer returned customer information request (cir) on (b)(6)2022.Consumer informed that her husband and son had a reaction to the pad of the bandage.Consumer stated that medical treatment was required.Doctors prescribed steroid cream.Consumer stated that the symptoms corrected after stopping using the product.In addition, consumer confirmed that the issue was with the pad area.

Manufacturer Narrative

As of 12/06/2022 aso has requested the batch record of the affected lot number, including retained samples for further testing.Aso reviewed records of satisfactory biocompatibility tests for this type of product with no issues noted.In addition, complaint database was reviewed and no negative trend has been identified for the associated product.Refer to section b.6 of this report for further details.As of 01/09/2023 aso received completed cir and unused product from the consumer.Unused product and retained samples were submitted to the lab for testing with no issues noted.

• Brand Name: EQUATE
• Type of Device: FLEXIBLE FABRIC BANDAGES ANTIBACTERIAL ASSORTED SIZES
• 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: aso complaints ; 300 sarasota center blvd.; sarasota, FL 34240
• MDR Report Key: 15962003
• MDR Text Key: 305336168
• Report Number: 1038758-2022-00049
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

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 Model Number: UPC#681131006712
• Device Lot Number: 00154603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2021
• 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 Sex: Male