MAUDE Adverse Event Report: ASO LLC WALMART-EQUATE; NASAL STRIPS

Model Number UPC 681131068437

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abrasion (1689); Burning Sensation (2146)

Event Date 06/15/2015

Event Type  Injury  

Event Description

On (b)(6) /2015 - the end user reported that the device ripped the skin off her nose.

Manufacturer Narrative

On (b)(6) 2015 pending lab testing of returned product.

• Brand Name: WALMART-EQUATE
• 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: 4922406
• MDR Text Key: 6016189
• Report Number: 1038758-2015-00049
• 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,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UPC 681131068437
• Device Catalogue Number: 552632418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 59