MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-01-29 for MIRA LUX MULTIFLEX TURBINE 635B 0553.2220 manufactured by Kaltenbach & Voigt Gmbh.
[797247]
Doctor was using a 635b handpiece and it came apart in the patient's mouth. The turbine and bur became lodged in patient's throat.
Patient Sequence No: 1, Text Type: D, B5
[7931172]
Patient was taken to er for treatment where they were able to remove the parts. Patient was reported to be in good condition. Patient did not require any medication, but requested an overnight stay at hospital. In 2008, doctor reported that patient was fine and he will see her in two weeks to complete dental work. Patient refused to return the components (turbine and bur) that allegedly lodged in her throat, therefore, a full evaluation could not be conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010493-2008-00002 |
| MDR Report Key | 988415 |
| Report Source | 05 |
| Date Received | 2008-01-29 |
| Date of Report | 2008-01-04 |
| Date of Event | 2008-01-02 |
| Date Mfgr Received | 2008-01-04 |
| Device Manufacturer Date | 2007-09-26 |
| Date Added to Maude | 2008-02-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARI LAMBERT |
| Manufacturer Street | 340 E. MAIN STREET |
| Manufacturer City | LAKE ZURICH IL 60047 |
| Manufacturer Country | US |
| Manufacturer Postal | 60047 |
| Manufacturer Phone | 8473643958 |
| Manufacturer G1 | KALTENBACH & VOIGT GMBH |
| Manufacturer Street | BISMARCKRING 39 |
| Manufacturer City | BIBERACH D-88400 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-88400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIRA LUX MULTIFLEX TURBINE 635B |
| Generic Name | DENTAL HANDPIECES AND ACCESSORIES |
| Product Code | KOJ |
| Date Received | 2008-01-29 |
| Returned To Mfg | 2008-01-09 |
| Model Number | 635B |
| Catalog Number | 0553.2220 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 957115 |
| Manufacturer | KALTENBACH & VOIGT GMBH |
| Manufacturer Address | BISMARCKRING 39 BIBERACH GM D-88400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-01-29 |