MAUDE Adverse Event Report: ASO LLC UP&UP; VALUE PACK ASSORTED BANDAGES 120CT

Model Number UPC#017276231625

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

Patient Problems Rash (2033); Scar Tissue (2060); Skin Tears (2516)

Event Date 02/10/2023

Event Type  Injury  

Manufacturer Narrative

As of (b)(6) 2023 aso submitted retained samples for testing with no defects or observations.Aso reviewed records of satisfactory biocompatibility tests and latex screening for all adhesive bandages added to the value pack with no issues noted.In addition, complaint database was reviewed and no negative trend has been identified for the associated product.

Event Description

On the initial report received by aso on (b)(6) 2023 consumer stated that the product peeled her skin, caused a rash, and left a mark/scar.The consumer said that she will need to see a dermatologist.

• Brand Name: UP&UP
• Type of Device: VALUE PACK ASSORTED BANDAGES 120CT
• 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 complaints ; 300 sarasota center blvd.; sarasota, FL 34240
• MDR Report Key: 16464943
• MDR Text Key: 310489751
• Report Number: 1038758-2023-00002
• 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: 03/01/2023

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 Model Number: UPC#017276231625
• Device Catalogue Number: 245070652
• Device Lot Number: 00171333
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2022
• 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 Sex: Female