MAUDE Adverse Event Report: ASO LLC BUBBLE GUPPIES; WATERPROOF ANTIBACTERIAL BANDAGES

Model Number UPC#017276234855

Device Problems Failure to Obtain Sample (2533); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rash (2033)

Event Date 03/25/2021

Event Type  Injury  

Manufacturer Narrative

As of 04/20/2021 aso has no received returned samples from consumer or lot info.However, aso reviewed records of biocompatibility tests with no issues noted.

Event Description

On the initial report received on 03/22/2021 consumer reported the product caused a reaction on her daughter.She stated the doctor told her it was an allergic reaction to the active ingredient, her daughter was prescribed antibiotic ointment 3 times a day for 5-7 days depending on healing.

• Brand Name: BUBBLE GUPPIES
• Type of Device: WATERPROOF ANTIBACTERIAL 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: 11715843
• MDR Text Key: 246995129
• Report Number: 1038758-2021-00016
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UPC#017276234855
• Device Catalogue Number: 573415520
• Date Manufacturer Received: 03/25/2021
• Was Device Evaluated by Manufacturer?: No
• 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