MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2005-12-02 for ELECTROTORQUE PLUS 25LHA 0553.5350 manufactured by Kavo Dental.
[413304]
A dentist reported that a pt received a second degree burn on her lip during the use of a 25lha handpiece. No medical intervention was required as a result of the incident. It was also reported that the handpiece had been used as a check retractor during the procedure. During a follow up call with the dentist in 05, it was reported that the pt has recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419798-2005-00006 |
| MDR Report Key | 649345 |
| Report Source | 05,07 |
| Date Received | 2005-12-02 |
| Date of Report | 2005-11-03 |
| Date of Event | 2005-11-02 |
| Date Mfgr Received | 2005-11-03 |
| Device Manufacturer Date | 2001-10-01 |
| Date Added to Maude | 2005-12-07 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOHN MILLER, DIR |
| Manufacturer Street | 901 WEST OAKTON STREET |
| 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 | 2005-12-02 |
| Returned To Mfg | 2005-11-07 |
| Model Number | 25LHA |
| Catalog Number | 0553.5350 |
| 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 | 638836 |
| 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 | 25LHA |
| Baseline Catalog No | 0553.5350 |
| 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 | 2005-12-02 |