MAUDE Adverse Event Report: ASO LLC UP & UP; ADHESIVE PADS

Model Number UPC#017276226355

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

Patient Problem Skin Tears (2516)

Event Date 01/09/2024

Event Type  Injury  

Event Description

On the initial report on (b)(6) 2024, the consumer stated that he had a cut on his leg and used the bandage on (b)(6) 2023.He tried taking it off on (b)(6) 2023, but he can't get it off.The adhesive is so stuck to his skin that it becomes bloody when removed.On the completed cir received by aso on 01/16/2024, the consumer states that he went to the er on (b)(6) 2023.Per cir, the consumer states that the issue was with the tape or adhesive area.

Manufacturer Narrative

As 02/02/2024, returned product and retained samples were submitted to the lab with no defects noted.In addition, aso reviewed records of satisfactory biocompatibility tests for this type of product with no issues noted.Refer to section b.6 of this report for further details.

• Brand Name: UP & UP
• Type of Device: ADHESIVE PADS
• 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 complaiints ; 300 sarasota center blvd.; sarasota ; 9413790300
• MDR Report Key: 18634908
• MDR Text Key: 334492383
• Report Number: 1038758-2024-00001
• 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: 02/02/2024

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#017276226355
• Device Lot Number: 00142806
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2021
• 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: Male