YETI POT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-11 for YETI POT manufactured by Changzhou Daya Import And Export Corporation Ltd.

Event Text Entries

[72838431] I had purchased a neti pot from (b)(6) which was called yeti pot. I used it last week with resulting reaction having severe swollen glands in my neck and congestion. It had happened to me previously about a month ago where i had to see my doctor about it as i had thought i had a flu. I used a better quality neti pot with no issues. I make my own saline solution with boiled water to treat my severe allergies. I think the brand name yeti pot from (b)(6) has some type of chemical reaction to saline water where i reacted with toxicity of my glands not working properly. I don't know if other people have had such reaction as i did. I have not gone to doctor about it this time. It occured to me was the brand neti pot. I would like to see this product removed from the market if it does cause other people to have such reactions like i had. I am concerned the yeti pot has inferior products being imported from (b)(6) where their lax quality of items are an issue. Please look into this and do something about this horrific product. I would appreciate your contacting me regarding this particular brand of nasal irrigation devices. I first visited doctor on (b)(6) with severe swollen glands in neck and severe congestion. I visited again on (b)(6) as i was not improving. Doctor prescribed methylprednisone and had a bad reaction to it and went to emergency room on (b)(6). Swollen glands went down considerably and i improved. I was better after this using a better quality of neti pot to nasal rinse my sinuses due to much pollen in air from my allergies. I have not seen a doctor yet about this past week. (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5069054
MDR Report Key6489359
Date Received2017-04-11
Date of Report2017-04-11
Date of Event2017-04-05
Date Added to Maude2017-04-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameYETI POT
Generic NameIRRIGATOR, SINUS
Product CodeKAR
Date Received2017-04-11
Model NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCHANGZHOU DAYA IMPORT AND EXPORT CORPORATION LTD


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Deathisabilit 2017-04-11

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