MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2005-06-24 for ELECTROTORQUE PLUS 25CHA 0553.5340 manufactured by Kavo Dental.
[418353]
A dentist reported that a pat received a burn on the inside of their cheek during the use of a 25cha handpiece. It was reported that the burned area appeared white in color. The pt was administered antibiotics (route and dose unknown) and an unknown ointment was applied to the burn. It was reported that the pt has since recovered. Additional information received revealed that the dr had used the handpiece to retract the pt's cheek while drilling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419798-2005-00003 |
| MDR Report Key | 617485 |
| Report Source | 05,07 |
| Date Received | 2005-06-24 |
| Date of Report | 2005-03-28 |
| Date of Event | 2005-03-01 |
| Date Mfgr Received | 2005-03-28 |
| Device Manufacturer Date | 1998-03-01 |
| Date Added to Maude | 2005-06-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOHN MILLER, DIRECTOR |
| Manufacturer Street | 901 WEST OAKTON ST |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 8476404924 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECTROTORQUE PLUS |
| Generic Name | ELECTRIC DENTAL HANDPIECE |
| Product Code | EKK |
| Date Received | 2005-06-24 |
| Returned To Mfg | 2005-03-28 |
| Model Number | 25CHA |
| Catalog Number | 0553.5340 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 607173 |
| Manufacturer | KAVO DENTAL |
| Manufacturer Address | 340 EAST MAIN ST. LAKE ZURICH IL 60047 US |
| Baseline Brand Name | ELECTROTORQUE PLUS |
| Baseline Generic Name | ELECTRIC DENTAL HANDPIECE |
| Baseline Model No | 25CHA |
| Baseline Catalog No | 0553.5340 |
| Baseline ID | NA |
| Baseline Device Family | ELECTROTORQUE PLUS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K934783 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-06-24 |