MAUDE Adverse Event Report: ASO LLC KROGER; NASAL STRIPS

Model Number UPC 4126037075

Device Problem Insufficient Information (3190)

Patient Problem Abrasion (1689)

Event Date 04/07/2015

Event Type  Injury  

Event Description

On (b)(6) 2015 - the end user reported that the device took a layer of skin from his nose and he has a bruise and scarring from this.

Manufacturer Narrative

On (b)(6) 2015 - the consumer did not provide product or a lot number for aso to conduct testing.

• Brand Name: KROGER
• Type of Device: NASAL STRIPS
• Manufacturer (Section D): ASO LLC; sarasota FL
• Manufacturer Contact: 300 sarasota center blvd.; sarasota, FL 34140 ; 9413790300
• MDR Report Key: 4817850
• MDR Text Key: 5919718
• Report Number: 1038758-2015-00021
• 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: 06/02/2015

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 4126037075
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/07/2015
• Initial Date FDA Received: 06/02/2015
• 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