STERIPOD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-27 for STERIPOD manufactured by Bonfit America.

Event Text Entries

[50959860] I purchased a toothbrush guard called steripod at (b)(6) because i wanted to have something to keep germs from getting on the head of my toothbrush. The packaging states that "active vapors" keep the toothbrush and bristles clean. A green liquid inside the "active vapors" pod leaked some mysterious fluid all over my toothbrush. When i looked online to see what it could be, i found steripod had no medical data or testing whatsoever to prove that it kept my toothbrush clean. In fact, with it being in an enclosed space with no airflow, i suspect that it's becoming a breeding ground for germs or bacteria when i use it. I had seen the same product for sale at (b)(6) and at (b)(6). I don't think they should be advertising this as a product that keeps toothbrushes clean when they haven't went to the trouble of doing any testing to show that actually works and may actually make the toothbrush more infested with germs.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5063744
• MDR Report Key: 5836192
• Date Received: 2016-07-27
• Date of Report: 2016-07-27
• Date of Event: 2016-07-05
• Date Added to Maude: 2016-08-01
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: STERIPOD
• Generic Name: STERIPOD
• Product Code: LRJ
• Date Received: 2016-07-27
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BONFIT AMERICA

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-07-27