MAUDE Adverse Event Report: ASO LLC EQUATE; ANTIBACTERIAL STRONG STRIPS ADHESIVE BANDAGES

Model Number UPC#017276236606

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

Patient Problem Abrasion (1689)

Event Date 07/23/2021

Event Type  Injury  

Manufacturer Narrative

The initial complaint by the customer did not indicate that an mdr would be required.However, per the info received on 07/23/2021 medical treatment was sought.Based on the information received, aso opted to file an mdr.As of 08/16/2021 aso evaluated unused returned and retained samples of the same lot with no defects noted.In addition, aso reviewed records of biocompatibility tests.

Event Description

On the initial report, received by aso on 06/21/2021 consumer stated that the product pulled off the skin on her arm, causing also pain.The completed customer information request (cir) received from the consumer on 07/23/2021, stated that the issue was with the tape and that she sought medical attention.

• Brand Name: EQUATE
• Type of Device: ANTIBACTERIAL STRONG STRIPS ADHESIVE BANDAGES
• 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: federico juliao ; 300 sarasota center blvd.; sarasota, FL 34240
• MDR Report Key: 12344903
• MDR Text Key: 267349535
• Report Number: 1038758-2021-00029
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UPC#017276236606
• Device Catalogue Number: 810464313
• Device Lot Number: 00134775
• Date Manufacturer Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2020
• 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