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

Model Number UPC#681131006743

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

Patient Problem Abrasion (1689)

Event Date 04/14/2023

Event Type  Injury  

Event Description

On the initial report received by aso on (b)(6)2023 consumer stated that when she pulled the product off, it took some of her skin.On (b)(6)2023, we received an email from the consumer stating that she will mail the product back to aso.Consumer states that the doctor said her skin would take 2-3 months to grow back.The consumer returned customer information request (cir) on (b)(6)2023.The consumer stated that she wore the bandages on her hand for about 2 hours.When she removed it, it took all the skin off where the tape area was.She went to the doctor and was told that the skin would take 2 to 3 months to grow back.The consumer confirmed that the issue was with the tape area.

Manufacturer Narrative

The initial complaint by the customer did not indicate that an mdr would be required.However, per the info received on 4/14/2023 medical treatment was sought.Based on the information received, aso opted to file an mdr.As of 05/04/2023 returned product and retained samples were submitted to the lab with no defects noted.In addition, aso reviewed records of satisfactory biocompatibility tests for this type of product with no issues noted.

• Brand Name: EQUATE
• Type of Device: HEAVY DUTY FABRIC BANDAGES ANTIBACTERIAL ALL ONE SIZE
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd.; sarasota FL
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd; sarasota FL
• Manufacturer Contact: 300 sarasota center blvd.
• MDR Report Key: 16881637
• MDR Text Key: 314683532
• Report Number: 1038758-2023-00010
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2022

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: 00174964
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/14/2023
• Initial Date FDA Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2023
• 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