MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-02-15 for GENTALPOWER LUX CONTR ANGLE 25LPA 1002.1526 manufactured by Kavo America.
[15034765]
The head of the handpiece became hot and burned the pt. Anti-inflammatory gel was applied to the burn. He healed fine.
Patient Sequence No: 1, Text Type: D, B5
[15230757]
The doctor was informed that there was a dent in the edge of the head of the handpiece that caused the head to heat up. In addition, maintenance info and settings were reviewed with the dr. Maintenance sheets were sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419798-2007-00002 |
| MDR Report Key | 818739 |
| Report Source | 05 |
| Date Received | 2007-02-15 |
| Date of Report | 2007-01-18 |
| Date of Event | 2007-01-16 |
| Date Mfgr Received | 2007-01-25 |
| Device Manufacturer Date | 2004-12-01 |
| Date Added to Maude | 2007-02-21 |
| 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 | 340 E ROUTE 22 |
| Manufacturer City | LAKE ZURICH IL 60047 |
| Manufacturer Country | US |
| Manufacturer Postal | 60047 |
| Manufacturer Phone | 8473643931 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENTALPOWER LUX CONTR ANGLE |
| Generic Name | * |
| Product Code | EKK |
| Date Received | 2007-02-15 |
| Returned To Mfg | 2007-01-25 |
| Model Number | 25LPA |
| Catalog Number | 1002.1526 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 806223 |
| Manufacturer | KAVO AMERICA |
| Manufacturer Address | 340 E ROUTE 22 LAKE ZURICH IL 60047 US |
| Baseline Brand Name | ELECTROTORQUE PLUS |
| Baseline Generic Name | ELECTRIC DENTAL HANDPIECE |
| Baseline Model No | 25LPA |
| Baseline Catalog No | 1002.1526 |
| 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. Required No Informationntervention | 2007-02-15 |