MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-04-23 for PERFORMER UNIT PREFORMER II (#8000) * manufactured by Adec.
[57148]
Chair and delivery system (dental) has two major design flaws. 1. Closed system for water irrigant used in pts' mouths prevents hook up to central water system and thereby facilitates growth of molds and bacteria due to standing and stagnant water in system. Mfr fails to provide info on how to disinfect and their design promotes these problems. Could be solved by allowing hook up to city water systems. 2. Suction unit design (saliva ejection) causes lines to kink and prevents lines from fully clearing with pt's saliva and blood. Prevents disinfection and definitely has cross contamination possibilities due to suck back by pts. Mfr was notified but has failed on three attempts to answer or provide solutions to these problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011174 |
| MDR Report Key | 85988 |
| Date Received | 1997-04-23 |
| Date of Report | 1997-04-15 |
| Date Added to Maude | 1997-04-25 |
| 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 |
| Reporter Occupation | DENTIST |
| 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 | PERFORMER UNIT |
| Generic Name | DENTAL DELIVERY SYSTEM |
| Product Code | KLC |
| Date Received | 1997-04-23 |
| Model Number | PREFORMER II (#8000) |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 85191 |
| Manufacturer | ADEC |
| Manufacturer Address | 2601 CRESTVIEW DR. NEWBERG OR 97132 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-04-23 |