BREATHE RIGHT NASAL STRIPS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-11-30 for BREATHE RIGHT NASAL STRIPS manufactured by Webtec A Division Of Scarpa Healthcare.

Event Text Entries

[61153288] This report is associated with argus case (b)(4), breathe right nasal strips.
Patient Sequence No: 1, Text Type: N, H10


[61153289] She also stated she had a stroke. She also stated she had a stroke and can not sleep. Consumer stated she needs a sleep mask, having trouble with her eyes. I'm needing a sleep mask. I have trouble with my eyes. Any kind of light bothers me/ sensitive to light. Case description: this case was reported by a consumer via interactive digital media and described the occurrence of stroke in a female patient who received breathe right nasal strips nasal strip (batch number unk, expiry date unknown) for drug use for unknown indication. On an unknown date, the patient started breathe right nasal strips. On an unknown date, an unknown time after starting breathe right nasal strips, the patient experienced stroke (serious criteria gsk medically significant, life threatening and other: gsk medically significant), difficulty sleeping, eye disorder and photophobia. The action taken with breathe right nasal strips was unknown. On an unknown date, the outcome of the stroke, difficulty sleeping, eye disorder and photophobia were unknown. It was unknown if the reporter considered the stroke, difficulty sleeping, eye disorder and photophobia to be related to breathe right nasal strips. Additional details, consumer reported that her dad used them he also died from cancer so thanks for helping him breath easy. She started using them after that just to try it in bad cold worked great now she was needing a sleep mask. She had stroke and had trouble eyes could not sleep any kind of light bothered her.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2320643-2016-00012
MDR Report Key6136083
Report SourceCONSUMER
Date Received2016-11-30
Date of Report2016-11-27
Date Mfgr Received2016-11-27
Date Added to Maude2016-11-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer StreetPO BOX 13398
Manufacturer CityRESEARCH TRIANGLE PARK NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone8888255249
Manufacturer G1GSK
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBREATHE RIGHT NASAL STRIPS
Generic NameNASAL STRIPS
Product CodeLWF
Date Received2016-11-30
Lot NumberUNK
OperatorLAY USER/PATIENT
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWEBTEC A DIVISION OF SCARPA HEALTHCARE
Manufacturer Address5900 MIDDLE VIEW WAY KNOXVILLE TN 37909 US 37909


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Other 2016-11-30

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