MAUDE Adverse Event Report: ASO LLC EQUATE; NASAL DILATOR

Model Number UPC 681131068420

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abrasion (1689)

Event Date 09/28/2015

Event Type  Injury  

Manufacturer Narrative

Representative retains and returned samples were evaluated with no defects observed.

Event Description

On (b)(6) 2015 the end user reported that the device peeled off part of her skin.She feels the adhesive is strong.No medical attention was sought.

• Brand Name: EQUATE
• Type of Device: NASAL DILATOR
• 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: 5227194
• MDR Text Key: 31314264
• Report Number: 1038758-2015-00089
• 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
• Report Date: 10/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/11/2020
• Device Model Number: UPC 681131068420
• Device Catalogue Number: 552632419
• Device Lot Number: 00034675
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/13/2015
• 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: 71 YR