MAUDE Adverse Event Report: NEILMED PHARMACEUTICAL, INC. NETI POT

Model Number REV# 320100506

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Respiratory Tract Infection (2420)

Event Date 01/20/2015

Event Type  Injury  

Event Description

Using the push bottle neti pot, i filled it with tap water as the directions showed in the picture for weeks now, and have developed a very severe sinus infection.Because of it this is my second round of antibiotics the doctor has tried me on two different antibiotics now to clear the sinus infection.The neti pot puts pressure behind my ears and the water gets stuck in my nasal passages.I feel that because the directions are falsified and shows you just a picture, that because i was informed and proper i've developed an infection that is harder to kill than normal.I also had bleeding when using the neti pot, after i blew my nose not a lot but, i've never had bleeding before.

• Brand Name: NETI POT
• Type of Device: NETI POT
• Manufacturer (Section D): NEILMED PHARMACEUTICAL, INC.
• MDR Report Key: 4454429
• MDR Text Key: 5425426
• Report Number: MW5040403
• Device Sequence Number: 1
• Product Code: KMA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2010
• Device Model Number: REV# 320100506
• Device Lot Number: 1108-ENU-US
• Other Device ID Number: 6520384-6669059
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 77