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

Model Number	UPC#681131006743
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On the initial report received by aso on 08/09/2024, the consumer stated that the product let him the exact shape of the bandage, which caused him a red chemical burn on his skin.On the completed consumer information report (cir) received on 08/29/2024, the consumer states that the pad part of the bandage left a very red rectangle over the area.The consumer consulted a nurse practitioner (pn), who told him that he probably had an allergic reaction to the bandage and that he should stop using the product.In addition, the consumer states that he used 3% hydrogen peroxide on a swap to clean the wound area before applying the bandage.
Additional Manufacturer Narrative
As of 09/23/2024, retained samples were submitted to the lab, and no defects were noted.In addition, aso reviewed records of production and satisfactory biocompatibility tests for this type of product, with no issues noted.Refer to section b.6 of this report for further details.Udi notes: the expiry date is not present on device label.

• Brand Name: EQUATE
• Common Device Name: HEAVY DUTY FABRIC BANDAGES ANTIBACTERIAL ALL ONE SIZE
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd.; sarasota 34240
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd; sarasota FL
• Manufacturer Contact: 300 sarasota center blvd.
• MDR Report Key: 20287009
• Report Number: 1038758-2024-00022
• Device Sequence Number: 8127280
• Product Code: KGX
• UDI-Device Identifier: 00681131006743
• UDI-Public: 00681131006743
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: 983368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2024

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#681131006743
• Device Catalogue Number: 566928135
• Device Lot Number: 208234
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male