MAUDE Adverse Event Report: ASO LLC WALGREENS; WATERPROOF SMART-FLEX ADHESIVE PADS

Model Number	UPC#311917011325
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abrasion (1689); Burning Sensation (2146); Skin Tears (2516)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As of 09/09/2024 retained samples of the same lot as the reported were submitted to the lab for testing 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.
Event or Problem Description
On the initial report received on (b)(6) 2024, the consumer stated that she used the product to cover dog scratches on her stomach and upper arm.She started feeling that the area was hurting, and once she removed the bandage, her skin came off.She went to urgent care.She was prescribed mupirocin and bactrim.
Event or Problem Description
On the initial report received on 08/12/2024, the consumer stated that she used the product to cover dog scratches on her stomach and upper arm.She started feeling that the area was hurting, and once she removed the bandage, her skin came off.She went to urgent care.She was prescribed mupirocin and bactrim.On the completed cir received from the consumer on (b)(6) 2024, the consumer states that she used the product from the evening to the following day; when she went to change it, the product burned her skin.The consumer states the issue was with the tape.However, the pad area was itchy too.
Additional Manufacturer Narrative
As on (b)(6) 2024, retained samples were submitted to the lab, and no defects were noted.In addition, aso reviewed records of production and satisfactory biocompatibility tests for this type of product, with no issues noted.Refer to section b.6 of this report for further details.Udi notes: the expiry date is not present on the device label.

• Brand Name: WALGREENS
• Common Device Name: WATERPROOF SMART-FLEX 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: 300 sarasota center blvd.; 9413790300
• MDR Report Key: 20170076
• Report Number: 1038758-2024-00021
• Device Sequence Number: 7058992
• Product Code: KGX
• UDI-Device Identifier: 00311917011325
• UDI-Public: 00311917011325
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 10/24/2024

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#311917011325
• Device Catalogue Number: 830427
• Device Lot Number: 215325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• 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