MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-12-12 for MIRA LUX MULTFLEX 635B OR RONDOFLEX manufactured by Kavo Dental.
[764882]
An air embolism was caused to patient's eye during procedure. While doctor was working on tooth 21, he noticed a percolation of the tissue. Patient's eye became red and puffy. Doctor said this was not an allergic reaction. Patient was prescribed clindamycin. Patient is healing. Doctor is not sure if it was caused by his 635b or his rondoflex.
Patient Sequence No: 1, Text Type: D, B5
[7935268]
Doctor refused to send in either item to kavo for repair. Doctor said nothing was wrong with the equipment. Doctor put pieces back into rotation, so the exact device used cannot be identified for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419798-2007-00025 |
| MDR Report Key | 962525 |
| Report Source | 05 |
| Date Received | 2007-12-12 |
| Date of Report | 2007-11-12 |
| Date of Event | 2007-11-09 |
| Date Mfgr Received | 2007-11-12 |
| Date Added to Maude | 2007-12-18 |
| 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, MANAGER |
| Manufacturer Street | 340 EAST MAIN ST. |
| Manufacturer City | LAKE ZURICH IL 60047 |
| Manufacturer Country | US |
| Manufacturer Postal | 60047 |
| Manufacturer Phone | 8473643958 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIRA LUX MULTFLEX 635B OR RONDOFLEX |
| Generic Name | TURBINE OR AIR-ABRASION SYSTEM W/SPRAY |
| Product Code | KOJ |
| Date Received | 2007-12-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 934640 |
| Manufacturer | KAVO DENTAL |
| Manufacturer Address | 340 E. ROUTE 22 LAKE ZURICH IL 60047 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-12-12 |