MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-03 for KL703 LED INTRALUX KL703LED manufactured by Kavo / Kalenbach And Voigt Gmbh.
[177883217]
Kavo kl703 led attachment ring unscrews while removing product from dental chair after pt care, for sterilization (routine use). The device falls apart. This has happened to approx 7-8 kl703 motors, and then require service. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092724 |
| MDR Report Key | 9665491 |
| Date Received | 2020-02-03 |
| Date of Report | 2020-01-30 |
| Date Added to Maude | 2020-02-04 |
| 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 | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KL703 LED INTRALUX |
| Generic Name | CONTROLLER, FOOT, HANDPIECE AND CORD |
| Product Code | EBW |
| Date Received | 2020-02-03 |
| Model Number | KL703LED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KAVO / KALENBACH AND VOIGT GMBH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-03 |