MAUDE Adverse Event Report: ASO LLC RITE AIR; NASAL STRIPS

Model Number UPC 01182261947

Device Problem Insufficient Information (3190)

Patient Problem Abrasion (1689)

Event Type  Injury  

Event Description

(b)(6) 2015: the end user reported his nose has been cut on each side.The device is cutting into his nose as he is sleeping.

Manufacturer Narrative

Unable to complete, customer returned product to the store and it was not forwarded to aso.

• Brand Name: RITE AIR
• Type of Device: NASAL STRIPS
• Manufacturer (Section D): ASO LLC; sarasota FL
• Manufacturer Contact: 300 sarasota center blvd.; sarasota, FL 34240 ; 9413790300
• MDR Report Key: 4826807
• MDR Text Key: 5839201
• Report Number: 1038758-2015-00025
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 06/05/2015

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 Operator: Lay User/Patient
• Device Model Number: UPC 01182261947
• Device Catalogue Number: 0361947
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2015
• Initial Date FDA Received: 06/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1