MAUDE Adverse Event Report: ASO LLC EQUATE; WATERSHIELD PLUS ANTIBACTERIAL ADHESIVE BANDAGES

Model Number UPC#681131349826

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

Patient Problems Burning Sensation (2146); Skin Inflammation/ Irritation (4545)

Event Date 07/11/2022

Event Type  Injury  

Event Description

On the initial report received by aso on 06/23/2022.Consumer reported the product left red (burn like) marks where the pad of the product touched her daughter's skin on her leg and arm.On completed cir received on 07/11/2022.Consumer stated sought medical attention for her 6 year old daughter at the emergency room, and they recommended to wrap.She added the symptoms corrected after stopped using the product.

Manufacturer Narrative

As of 07/15/2022.Unused returned samples and unused retained product from the same lot were submitted to the lab for testing with no defects noted.In addition, aso reviewed records of biocompatibility tests and latex screening.

• Brand Name: EQUATE
• Type of Device: WATERSHIELD PLUS ANTIBACTERIAL 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: aso complaiints ; 300 sarasota center blvd.; sarasota, FL 34240
• MDR Report Key: 15257568
• MDR Text Key: 298206831
• Report Number: 1038758-2022-00031
• 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: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: UPC#681131349826
• Device Catalogue Number: 579329705
• Device Lot Number: 00161464
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2022
• 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 Age: 6 YR
• Patient Sex: Female