MAUDE MDR 6489359

MDR report key
6489359
Report number
MW5069054
Event key
0
Event type
3
Date of event
2017-04-05
Date received
2017-04-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Related Records

Manufacturer Contact

Report source
P
Manufacturer link flag
N

Devices

SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1YETI POTIRRIGATOR, SINUSCHANGZHOU DAYA IMPORT AND EXPORT CORPORATION LTDKARNAI Y

Patients

SequenceReceivedTreatmentOutcome
12017-04-1101. O; 2. S

Event Narratives

D

Patient 1

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).

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