MAUDE Adverse Event Report: SCAPA TAPES NORTH AMERICA, LLC BREATHE RIGHT EXTRA CLEAR NASAL STRIP; NASAL STRIPS

Lot Number CONFIDENTIAL

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

Patient Problems Dry Eye(s) (1814); Visual Impairment (2138)

Event Date 01/01/2021

Event Type  Injury  

Event Description

This mdr was originally received on 07-jan-2022 however the case was not assessed as serious and reportable as a 30-day mdr until additional information was received during follow-up on 07-march-2022.On (b)(6) 2022, a spontaneous report from the united states was received from a consumer via telephone regarding an (b)(6) male who used breathe right extra clear nasal strips.On 07-mar-2022, additional information was received, and the report was assessed to be a reportable medical device complaint.Medical history included diabetes, high blood pressure, and high cholesterol.Allergies included penicillin and latex.Concomitant products included metformin, an unspecified cholesterol medication, and an unspecified high blood pressure medication.On an unspecified date, reported as for "years", the consumer started using breathe right extra clear nasal strips applied topically for an unspecified indication.On an unspecified date, after using the product and "maybe 3-6 months ago" (relative to (b)(6) 2022; further clarified it was some time after using the product), he started having issues focusing his vision.He had been to an eye doctor at least three times and they could not find anything wrong other than dry eyes.Subsequently, dry eye drops were recommended.The consumer noted the packaging stated it contained latex, but no latex was in the actual product.On (b)(6) 2022, it was learned that the consumer still had some focusing issues and dry eyes.He clarified that when he first visited his doctor, he was given a new stronger prescription for glasses.He returned to his doctor a couple of times due to his focusing issues and dry eyes and was told there was nothing wrong.As of (b)(6) 2022, he continued to use the eye drops and he felt the same.No additional information was provided.This report is made by fcb without prejudice and does not imply any admission or liability for the incident or its consequences.

Manufacturer Narrative

The complaint sample was not available for evaluation.Test results confirm retain samples from the same lot met specifications and no issues were observed during the manufacturing of this lot.

• Brand Name: BREATHE RIGHT EXTRA CLEAR NASAL STRIP
• Type of Device: NASAL STRIPS
• Manufacturer (Section D): SCAPA TAPES NORTH AMERICA, LLC; 2565 bertelkamp lane; knoxville TN 37931
• Manufacturer (Section G): SCAPA TAPES NORTH AMERICA, LLC; 2565 bertelkamp lane; knoxville TN 37931
• Manufacturer Contact: 106 isabella street, suite 602; pittsburgh, PA 15212 ; 4125332442
• MDR Report Key: 14017007
• MDR Text Key: 293631677
• Report Number: 3010200299-2022-00001
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: CONFIDENTIAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CHOLESTEROL MEDICATION (UNSPECIFIED); HIGH BLOOD PRESSURE MEDICATION (UNSPECIFIED); METFORMIN
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male