MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-22 for CVS HEALTH EXTRA STRENGTH NASAL STRIPS manufactured by Glaxosmithkline.
[100955070]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075456 |
| MDR Report Key | 7292570 |
| Date Received | 2018-02-22 |
| Date of Report | 2018-02-20 |
| Date of Event | 2018-02-14 |
| Date Added to Maude | 2018-02-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CVS HEALTH EXTRA STRENGTH NASAL STRIPS |
| Generic Name | CVS HEALTH EXTRA STRENGTH NASAL STRIPS |
| Product Code | LWF |
| Date Received | 2018-02-22 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | GLAXOSMITHKLINE |
| Brand Name | CVS HEALTH EXTRA STRENGTH NASAL STRIPS |
| Generic Name | CVS HEALTH EXTRA STRENGTH NASAL STRIPS |
| Product Code | LWF |
| Date Received | 2018-02-22 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-22 |