MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-15 for H2OFLOSS ORAL IRRIGATOR MODEL HF-9 WHISPER NA manufactured by Shenzhen Bft Electrical Applianc/ Shenzhen Baofengtong Electrical Appliances Manufacturing Co..
[175696001]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092265 |
| MDR Report Key | 9595887 |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-13 |
| Date of Event | 2019-12-11 |
| Date Added to Maude | 2020-01-16 |
| 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 | 3 |
| Brand Name | H2OFLOSS ORAL IRRIGATOR MODEL HF-9 WHISPER |
| Generic Name | UNIT, ORAL IRRIGATION |
| Product Code | EFS |
| Date Received | 2020-01-15 |
| Model Number | HF-9 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHENZHEN BFT ELECTRICAL APPLIANC/ SHENZHEN BAOFENGTONG ELECTRICAL APPLIANCES MANUFACTURING CO. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-15 |