MAUDE Adverse Event Report: APOTHECARY PRODUCTS LLC NETI RINSE SINUS KIT; NASAL IRRIGATOR

Model Number 400764A

Device Problems Use of Device Problem (1670); Failure to Clean Adequately (4048)

Patient Problem Meningitis (2389)

Event Date 08/29/2022

Event Type  Injury  

Event Description

A customer informed e-commerce platform alleging that after using our nasal irrigator on her child, the child got bacterial meningitis and had to undergo surgeries for installing cochlear implant.According to the customer the child lost hearing capability.

Manufacturer Narrative

The customer did not provide sufficient data to help investigate further.We believe that our device could not cause this to the child if used as directed on the label which is in accordance with fda recommendation for using nasal irrigator.We anticipate that the customer could have used tap water to irrigate, or the syringe was not cleaned before use.Our label clearly states that only use boiled and cooled water or distilled water for irrigation.We do not have any other complaint for this product.The customer did not provide the age of the child, our label clearly states "product should be use only by those who can understand and follow all instructions".With the information provided to date, we conclude that our nasal irrigation devices are safe and effective when used in accordance with the instructions for safe use provided with the product.The information provided by apothecary products was from our customer which is e-commerce platform and not the user of the device.

• Brand Name: NETI RINSE SINUS KIT
• Type of Device: NASAL IRRIGATOR
• Manufacturer (Section D): APOTHECARY PRODUCTS LLC; 11750 12th avn south; burnsville MN 55337
• Manufacturer (Section G): APOTHECARY PRODUCTS LLC; 11750 12th avn south; burnsville MN 55337
• Manufacturer Contact: pankaj jitiya ; 11750 12 th avn south; burnsville, MN 55337 ; 9528088330
• MDR Report Key: 15402386
• MDR Text Key: 299692894
• Report Number: 0002183-2022-00005
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 400764A
• Device Catalogue Number: 400764A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization