MAUDE Adverse Event Report: ASO LLC EQUIATE; PLASTIC BANDAGES ANTIBACTERIAL

Model Number UPC#681131006774

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 11/08/2023

Event Type  Injury  

Event Description

On the initial report on 10/05/2023, the consumer reported that she had an allergic reaction.The consumer returned the customer information request (cir) on (b)(6) 2023.The consumer stated that she had a tele-doc visit.She was treated with steroids and an antihistamine to calm the itch and burn.The consumer states that the affected area becomes worse after steroid treatment, she went to the family doctor and was prescribed more steroid treatment.The consumer states that she is diabetic.

Manufacturer Narrative

As of (b)(6) 2023 unused retained/returned product was submitted to the lab for testing, with no defects noted.In addition, aso has reviewed records of biocompatibility tests and latex screening.Refer to section b.6 of this report for further details.

• Brand Name: EQUIATE
• Type of Device: PLASTIC 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: aso complaints ; 300 sarasota center blvd.; sarasota, FL 34204
• MDR Report Key: 18187111
• MDR Text Key: 328737397
• Report Number: 1038758-2023-00031
• 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
• Report Date: 11/21/2023

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#681131006774
• Device Lot Number: 00168406
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2022
• 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: Female