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 Abrasion (1689); Rash (2033)

Event Date 03/10/2022

Event Type  Injury  

Manufacturer Narrative

As of 04/04/2022 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.

Event Description

On the initial report received by aso on 03/10/2022 consumer reported the product took off a piece of skin upon removal and caused also a rash.On completed cir received on 03/30/2022 consumer stated the issue was with the tape area, and that she sought medical attention and was prescribed steroid cream, tylenol and motrin.Additionally, consumer stated the symptoms corrected after stopped using the product and treating with prescribed steroid cream.

• 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: federico juliao ; 300 sarasota center blvd.; sarasota, FL 34240
• MDR Report Key: 14043259
• MDR Text Key: 288794236
• Report Number: 1038758-2022-00007
• 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: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• 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: 00145663
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2021
• 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