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

Model Number	UPC# 017276229929
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	08/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On the initial report received by aso on 08/19/2024, the consumer stated that when she removed the product, her skin was removed, and busted capillaries on her nose.We received completed customer information request (cir) from the consumer on 08/30/2024.The consumer stated that the product broke capillaries from the tape and strip expansion.Per cir the consumer states that the doctor recommends laser treatment.
Additional Manufacturer Narrative
As 09/23/2024 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.Udi notes: the expiry date is not present on the device label.

• Brand Name: TARGET
• Common Device Name: EXTRA STRENGTH NASAL STRIPS CLEAR
• 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 34240
• MDR Report Key: 20300813
• Report Number: 1038758-2024-00023
• Device Sequence Number: 8686722
• Product Code: LWF
• UDI-Device Identifier: 00017276229929
• UDI-Public: 00017276229929
• 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): 09/25/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: UPC# 017276229929
• Device Catalogue Number: 094030445
• Device Lot Number: 208952
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 09/25/2024
• 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