MAUDE Adverse Event Report: ASO LLC EQUATE; NASAL DILATOR EXTRA STRENGTH CLEAR

Model Number UPC681131112185

Device Problem Failure to Obtain Sample (2533)

Patient Problem Abrasion (1689)

Event Date 04/25/2016

Event Type  Injury  

Manufacturer Narrative

Aso was notified on the complaint on (b)(6) 2016 and has made several attempts to contact the consumer requesting further information on the device.The consumer has not responded to the requests.Aso will follow-up on this report if the consumer responds to the request for further information and return samples of unused product.However, aso reviewed records of biocompatibility tests performed on materials used to manufacture the same type of products.No lot number or samples returned.

Event Description

Consumer reported that the adhesive from the strip stuck and she was trying to get it off but nothing worked and device ripped off her skin on the right side of her nose.Consumer sought medical attention.

Manufacturer Narrative

Aso was notified on the complaint on (b)(6) 2016 and has made several attempts to contact the consumer requesting further information on the device.The consumer has not responded to the requests.Aso will follow-up on this report if the consumer responds to the request for further information and return samples of unused product.However, aso reviewed records of biocompatibility tests performed on materials used to manufacture the same type of products.In 06/24/2016 aso received further information from the consumer as well as returned samples.Aso evaluated returned samples as well as retained samples of the same lot number.

Event Description

Consumer reported that the adhesive from the strip stuck and she was trying to get it off but nothing worked and device ripped off her skin on the right side of her nose.Consumer sought medical attention.

• Brand Name: EQUATE
• Type of Device: NASAL DILATOR EXTRA STRENGTH 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: federico juliao ; 300 sarasota center blvd.; sarasota, FL 34240 ; 9413790300
• MDR Report Key: 5680547
• MDR Text Key: 45959094
• Report Number: 1038758-2016-00072
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/12/2021
• Device Model Number: UPC681131112185
• Device Catalogue Number: 553994071
• Device Lot Number: 43019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 86