MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-06-15 for STYLUS EASYCARE 790500 manufactured by Dentsply Professional.
[474671]
A pt was burned after coming into contact with a handpiece which reportedly overheated. No blister or marking was present and no medical treatment was required.
Patient Sequence No: 1, Text Type: D, B5
[7841252]
In this event a doctor reported that a pt was burned after coming into contact with a handpiece which reportedly overheated. Though no medical intervention was required to treat the burn in this event, there have been previously reported events involving similar devices that resulted in the need for medical/surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. Consequently, it must be presumed that recurrence of this malfunction is likley to result in a serious injury. The device was repaired and returned prior to receiving information that made this event reportable. However, the repair notes indicate that the cap was stuck in the downed position and the pusher was drilling through the cap. Additionally, a dhr review was conducted for the lot involved in this event as well as the lots manufactured immediately prior and subsequent to this lot; no abnormalities were noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419322-2006-00267 |
| MDR Report Key | 726519 |
| Report Source | 05 |
| Date Received | 2006-06-15 |
| Date of Report | 2006-05-16 |
| Date Mfgr Received | 2006-05-16 |
| Device Manufacturer Date | 2003-07-01 |
| Date Added to Maude | 2006-06-19 |
| 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 | DR. PATRICIA KIHN |
| Manufacturer Street | 221 W. PHILA. ST. STE. 60 |
| Manufacturer City | YORK PA 17404 |
| Manufacturer Country | US |
| Manufacturer Postal | 17404 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY PROFESSIONAL |
| Manufacturer Street | 901 WEST OAKTON ST. |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60018 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STYLUS EASYCARE |
| Generic Name | EFB |
| Product Code | EFS |
| Date Received | 2006-06-15 |
| Returned To Mfg | 2006-05-16 |
| Model Number | NA |
| Catalog Number | 790500 |
| Lot Number | 070203 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 714833 |
| Manufacturer | DENTSPLY PROFESSIONAL |
| Manufacturer Address | * DES PLAINES IL * US |
| Baseline Brand Name | STYLUS EASYCARE |
| Baseline Generic Name | DENTAL HANDPIECE |
| Baseline Model No | NA |
| Baseline Catalog No | 790500 |
| Baseline ID | NA |
| Baseline Device Family | STYLUS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K003518 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-15 |