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

Model Number UPC#681131006729

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

Patient Problems Skin Tears (2516); Skin Inflammation/ Irritation (4545)

Event Date 03/20/2024

Event Type  Injury  

Event Description

On the initial report received by aso on 02/05/2024, the consumer states that the bandages could not come off her skin safely, leaving a horrible rash.On the completed consumer information report (cir) received on 02/29/2024, she states that she went to the physician, and the doctor prescribed ointment.Per cir, the consumer states that the issue was with the tape area.

Manufacturer Narrative

As of 03/11/2024 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.

Manufacturer Narrative

As of 03/11/2024 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 03/20/2024 the following section was updated: b6 (revised testing information with no other changes required as a result of updating this section).

Event Description

On the initial report received by aso on 02/05/2024, the consumer states that the bandages could not come off her skin safely, leaving a horrible rash.On the completed consumer information report (cir) received on 02/29/2024, she states that she went to the physician, and the doctor prescribed ointment.Per cir, the consumer states that the issue was with the tape area.

• Brand Name: EQUATE
• Type of Device: FLEXIBLE 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 34240
• Manufacturer Contact: aso complaints ; 300 sarasota center blvd.; 9413790300
• MDR Report Key: 18934201
• MDR Text Key: 338033756
• Report Number: 1038758-2024-00004
• 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: 03/27/2024

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#681131006729
• Device Lot Number: 00182426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2023
• 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