MAUDE Adverse Event Report: ASO LLC EQUATE CLEAR NASAL STRIPS MED. 30CT.; NASAL DILATORS

Model Number 681131068420

Device Problem Material Integrity Problem (2978)

Patient Problem Injury (2348)

Event Date 08/08/2015

Event Type  Injury  

Manufacturer Narrative

09/28/15 - the consumer/end user provided additional information stating that the event remediated, symptoms corrected after she stopped using the product.Device evaluated by manufacturer - evaluation of a representative sample of the related medical device.

Event Description

(b)(6) 2015 - consumer/end-user reported that the adhesive on the device/product was too strong.She tried to remove the strip, after using the product overnight, and it peeled the skin right off of her nose.

• Brand Name: EQUATE CLEAR NASAL STRIPS MED. 30CT.
• 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: steve walter ; 300 sarasota center blvd.; sarasota, FL 34240 ; 9413790300
• MDR Report Key: 5223725
• MDR Text Key: 31196753
• Report Number: 1038758-2015-00082
• Device Sequence Number: 1
• Product Code: LWF
• UDI-Device Identifier: 00681131068420
• UDI-Public: 681131068420
• 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: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/17/2020
• Device Model Number: 681131068420
• Device Catalogue Number: 552632419
• Device Lot Number: 00031008
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR