MAUDE Adverse Event Report: ASO LLC UP&UP; WATERPROOF HEAVY DUTY DURABLE BANDAGES

Model Number	UPC#017276233094
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On the initial report on (b)(6)2024, the consumer states that when she removed the bandages, a piece of skin was also removed resulting in burning sensation.No medical attention was sought.On the completed consumer information report (cir) received on (b)(6)2024, the consumer states that she used the bandage over a wound to shower the next day and tried removing the bandage and removing her skin.The consumer went to the urgent care.The doctor prescribed a cream.The consumer states that she has discoloration and bruising on her skin.
Additional Manufacturer Narrative
As of 12/04/2024 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.Due to an oversight, there was a delay in filing this report.However, this delay did not impact the outcome of the investigation.Udi notes: the expiry date is not present on the device label.

• Brand Name: UP&UP
• Common Device Name: WATERPROOF HEAVY DUTY DURABLE 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: aso complaints ; 300 sarasota center blvd.; sarasota, FL 34240 ; 9413790300
• MDR Report Key: 20846950
• Report Number: 1038758-2024-00031
• Device Sequence Number: 14435603
• Product Code: KGX
• UDI-Device Identifier: 00017276233094
• UDI-Public: 00017276233094
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2024

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#017276233094
• Device Catalogue Number: 245070576
• Device Lot Number: 208771
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female