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 Problems Skin Irritation (2076); Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

As of 09/06/2019 aso have not received lot number information or returned samples from the consumer, so we have been unable to perform testing.Aso reviewed records of biocompatibility tests and latex screening.Refer to this report for further details.

Event Description

On the initial report on 07/19/2019 consumer reported the product caused a chemical burn on child.On a call received on 8/12/2019 reporter stated that sought medical attention for the child.

• 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: 8984345
• MDR Text Key: 159517206
• Report Number: 1038758-2019-00034
• 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: 07/19/2019

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 Operator: No Information
• Device Model Number: UPC#017276234855
• Device Catalogue Number: 573415520
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 09/10/2019
• 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