MAUDE Adverse Event Report: SNORESTOP ECOMERZPRO ANTI-SNORING SEPTUM; DEVICE, ANTI-SNORING

Model Number SNORE STOP

Device Problem Material Integrity Problem (2978)

Patient Problems Headache (1880); Pain (1994)

Event Date 05/30/2021

Event Type  Injury  

Event Description

I ordered a "snore-stop" nasal device, but turned out it was a knock-off.Thought site was in n.America, but it's not.Ordered snore-stop device (b)(6) 2021.Took 2 weeks to deliver.Device sent was something similar but not what was advertised.I tried it anyway and day 3 i started have severe eardrum aches and frontal lobe headaches.I've asked to return, but no reply since (b)(6).I was told by customer service rep., (b)(6), that they are just an (b)(6) platform like (b)(6) and products patented and safe.There is no way to return as they won't give you product's mfr.Info.Fda safety report id # (b)(4).

• Brand Name: ECOMERZPRO ANTI-SNORING SEPTUM
• Type of Device: DEVICE, ANTI-SNORING
• Manufacturer (Section D): SNORESTOP; 591 constitution avenue # a; camarillo CA 93012
• MDR Report Key: 11929841
• MDR Text Key: 254367572
• Report Number: MW5101680
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): Y
• 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: 05/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SNORE STOP
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 91