MAUDE Adverse Event Report: ASO LLC EQUATE; NASAL DILATORS

Model Number UPC 681131112185

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

Patient Problem Abrasion (1689)

Event Date 10/23/2015

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2015: customer was contacted several times with an attempt to obtain returned product.Representative samples from retained samples were evaluated with no issues noted.In addition to adhesion testing, biocompatibility data is available on representative product.

Event Description

On (b)(6) 2015: the end user alleged that the device caused his skin to peel off on the outside when he took the device off.

• Brand Name: EQUATE
• Type of Device: NASAL DILATORS
• 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: 5242546
• MDR Text Key: 31816307
• Report Number: 1038758-2015-00101
• 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: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2020
• Device Model Number: UPC 681131112185
• Device Catalogue Number: 553990471
• Device Lot Number: 00035559
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2015
• 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: 76 YR
• Patient Weight: 84