Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GLAXOSMITHKLINE CVS HEALTH EXTRA STRENGTH NASAL STRIPS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GLAXOSMITHKLINE CVS HEALTH EXTRA STRENGTH NASAL STRIPS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Bruise/Contusion (1754); Headache (1880); Discomfort (2330)
Event Date 02/14/2018
Event Type  Injury  
Event Description
Around 11:30 pm on (b)(6) 2018, i put a clear cvs health extra strength nasal strip (purchased over the counter at cvs) on the bridge of my nose as per the instructions of the package.When i woke up the next morning, at approximately 7:30 am on (b)(6) 2018, i noticed a large purple/black spot on my nose when i removed the nasal strip.The area was also a bit tender.Almost a week later, i still have a bruise/skin irritation on my nose, although it has dissipated slightly.I immediately contacted cvs and filed a report.I also had a slight headache for two days following use of the nasal strip.The product in question can be found online at: https://www.Cvs.Com/shop/cvs-health-extra-strength-nasal-strips-26ct-prodid-1011889?(b)(4) name of company that makes (or compounds) the product: cvs.Is the product over-the-counter: yes.Frequency: at bedtime.How was it taken or used: transdermal.Date the person first started taking or using the product: (b)(6) 2018.Date the person stopped taking or using the product: (b)(6) 2018.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CVS HEALTH EXTRA STRENGTH NASAL STRIPS
Type of Device
CVS HEALTH EXTRA STRENGTH NASAL STRIPS
Manufacturer (Section D)
GLAXOSMITHKLINE
MDR Report Key7292570
MDR Text Key100955070
Report NumberMW5075456
Device Sequence Number0
Product Code LWF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2018
Is this an Adverse Event Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Age41 YR
Patient Weight85
-
-