MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-08-21 for SCHEIN DENTAL ULTIMA 5000 II SE NI manufactured by Ultima Dental Systems.
[233662]
The suction hose of the mobile dental cart becomes separated, reversing the air flow. This results in expelling of contents of the collection receptacle, possibly contaminating pts and medical personnel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003116 |
| MDR Report Key | 354741 |
| Date Received | 2001-08-21 |
| Date of Report | 2001-08-21 |
| Date of Event | 2001-04-01 |
| Date Added to Maude | 2001-10-10 |
| 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 | PATIENT |
| 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 | SCHEIN DENTAL ULTIMA 5000 II SE |
| Generic Name | SUCTION HOSE |
| Product Code | EHZ |
| Date Received | 2001-08-21 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 343961 |
| Manufacturer | ULTIMA DENTAL SYSTEMS |
| Manufacturer Address | 2621 N W 17TH LANE POMPANO BEACH FL 33064 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-08-21 |