MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-12 for "WATER FIXER" UV WATER STERILIZER 1000 manufactured by Water Technology Div. The Csh Group, Inc..
[8349]
The device is a sterilizer unit that is attached to the water source in dental units. The literature that is supplied by the mfr cites aerosolized water from the dental unit handpiece and 3-way syringe as a source of infection for dental personnel as well as pts. According to the jada, 10/93, as well as numerous other reports in the literature, the major source of bacterial contamination of dental unit waterlines is the biofilm that forms on the inside of the tubing which the device does nothing to eliminate. The mfr suggests connecting the device to the dental unit water source to eliminate bacteria and viruses in aerosols. According to rptr this simply does not work. (*)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1000479 |
| MDR Report Key | 11050 |
| Date Received | 1994-01-12 |
| Date of Report | 1993-12-28 |
| Date Added to Maude | 1994-01-26 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | "WATER FIXER" UV WATER STERILIZER |
| Product Code | EKY |
| Date Received | 1994-01-12 |
| Model Number | 1000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11050 |
| Manufacturer | WATER TECHNOLOGY DIV. THE CSH GROUP, INC. |
| Manufacturer Address | UNKNOWN * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-01-12 |