MAUDE Adverse Event Report: ASO LLC UP&UP; STRONG-STRIPS WATERPROOF BANDAGES

Model Number UPC#017276233094

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

Patient Problems Abscess (1690); Burning Sensation (2146)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

As of 09/22/2020 unused retained samples of the same lot reported were submitted to the lab for testing with no defects noted.Aso reviewed records of biocompatibility tests.In addition, the bandage labeling states that the product is not intended to be applied on delicate or sensitive skin.

Event Description

On the initial report received by aso on 08/24/2020, consumer informed that she applied the product to her toddler on the right lower leg and it caused a reaction similar to a chemical burn in the area and had a discharge as well (yellow green clear).Consumer stated would take her toddler to emergency room.

• Brand Name: UP&UP
• Type of Device: STRONG-STRIPS WATERPROOF 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: 10576883
• MDR Text Key: 208318254
• Report Number: 1038758-2020-00039
• 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: 09/23/2020

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#017276233094
• Device Catalogue Number: 0245070576
• Device Lot Number: 00121216
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2020
• 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