MAUDE Adverse Event Report: NEILMED PHARMACEUTICALS, INC. NEILMED SINUGATOR CORDLESS PULSATING NASAL WASH KIT WITH ONE IRRIGATOR, 30 PREMI; IRRIGATOR, POWERED NASAL

Model Number SG-ENU-INT

Device Problems Corroded (1131); Moisture Damage (1405); Structural Problem (2506); Explosion (4006)

Patient Problem Eye Injury (1845)

Event Date 05/05/2021

Event Type  Injury  

Event Description

Device exploded, eye damaged; item model# sg-enu-int, "(b)(4)" i was able to use this 4 times.Not 4 weeks, 4 days, 4 hours.Probably about 4 minutes.That's it, the item exploded causing injury.After finding out that (b)(6) would not take a return and the seller would not allow me to return it.The problem is that this thing is not sealed properly.The top cap part that holds the nozzle has no seal at all.The motor was saturated.The circuit board switches were actually corroded.Fda safety report id # (b)(4).

• Brand Name: NEILMED SINUGATOR CORDLESS PULSATING NASAL WASH KIT WITH ONE IRRIGATOR, 30 PREMI
• Type of Device: IRRIGATOR, POWERED NASAL
• Manufacturer (Section D): NEILMED PHARMACEUTICALS, INC.
• MDR Report Key: 12142286
• MDR Text Key: 260703912
• Report Number: MW5102400
• 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: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SG-ENU-INT
• Device Lot Number: M050112
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 38 YR
• Patient Weight: 84