MAUDE Adverse Event Report: ASO LLC CVS; NASAL DILATOR

Lot Number A512240

Device Problem Insufficient Information (3190)

Patient Problems Abrasion (1689); Scar Tissue (2060)

Event Date 04/23/2015

Event Type  Injury  

Event Description

(b)(6) 2015: the end user reported that the adhesive on the device took some skin off his nose and made him bleed.He now has a scab.

Manufacturer Narrative

Customer has not provided returned product, unable to complete at this time.Customer indicated to our customer that he did not want to pursue further with this report unless it gets infected.

• Brand Name: CVS
• Type of Device: NASAL DILATOR
• Manufacturer (Section D): ASO LLC; sarasota FL
• Manufacturer Contact: 300 sarasota center blvd.; sarasota, FL 34240 ; 9413790300
• MDR Report Key: 4826793
• MDR Text Key: 5838199
• Report Number: 1038758-2015-00027
• 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

• Date FDA Received: 06/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: A512240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1