MAUDE Adverse Event Report: ASO LLC CLEAR PASSAGE; NASAL STRIPS EXTRA STRENGTH TAN STRIPS

Model Number UPC#017276232967

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 12/01/2022

Event Type  Injury  

Manufacturer Narrative

Aso laboratory completed testing of retain samples with no issues noted.Aso reviewed records of satisfactory biocompatibility tests for this type of product with no issues noted.In addition, complaint database was reviewed and no negative trend has been identified for the associated product.

Event Description

Consumer stated on (b)(6) 2022 that product left a mark upon removal.His doctor treated with hydroquinone cream.

• Brand Name: CLEAR PASSAGE
• Type of Device: NASAL STRIPS EXTRA STRENGTH TAN STRIPS
• 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: 16054869
• MDR Text Key: 306246613
• Report Number: 1038758-2022-00051
• Device Sequence Number: 1
• Product Code: LWF
• 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: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: UPC#017276232967
• Device Lot Number: 00164039
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2022
• 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: Male