MalfunctionEFS
H2OFLOSS ORAL IRRIGATOR MODEL HF-9 WHISPER
Received Jan 15, 2020 · Event occurred Dec 11, 2019
Report MW5092265 · MDR key 9595887
Device
Generic name
Unit, Oral Irrigation
Manufacturer
Shenzhen Bft Electrical Applianc/ Shenzhen Baofengtong Electrical Appliances Manufacturing Co.Model number
HF-9Catalog number
NA
Lot number
NA
Product problems
- Device Contamination with Chemical or Other Material
Patient
69 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
I SAW BLACK MOLD INSIDE THE CLEAR FLOSSING TUBE. I LOOKED IN THE MANUAL, AND THERE ARE NO INSTRUCTIONS FOR CLEANING THE LONG WHITE TUBE THAT PROVIDES WATER, OR THE CLEAR TUBES THAT FEED THE TIP OF THE H2OFLOSS WATER DENTAL FLOSSER. I TRIED RUNNING SOAPY WATER, THEN HYDROGEN PEROXIDE THROUGH IT. IT DID NOT HELP. FDA SAFETY REPORT ID # (B)(4).