FDA Adverse Event
Malfunction
Summary report: N
ELLMAN IEC NEUTRAL PLATE
MDR report key: 1024318
·
Received April 3, 2008
Report
- Report Number
- 2428235-2008-00001
- Event Type
- Malfunction
- Date Received
- April 3, 2008
- Date of Event
- February 13, 2007
- Report Date
- March 5, 2008
- Manufacturer
- ELLMAN INTERNATIONAL, INC.
- Product Code
- ODR
- PMA / PMN Number
- K992382
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PROBLEM WAS FOUND WITH WIRE AT THE CONNECTOR JUNCTION.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT SUFFERED LOSS OF GINGIVA DURING A PROCEDURE IN 2007. THE DENTIST WAITED TO SEE IF THE LOSS WAS REGENERATED. THERE WAS NO SIGN OF REGENERATING GINGIVA AFTER 6 MONTHS. THE DENTIST THEN PERFORMED GRAFTING TO FILL THE LOSS AND WAITED TO SEE HOW IT HEALED. THE DENTIST SAID THAT THE PROBLEM WAS DUE TO THE CUTTING POWER GETTING LOST AND SUDDENLY COMING BACK BY THE NEUTRAL PLATE CABLE WHICH WAS COMING DOWN WITHOUT AN ALARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELLMAN IEC NEUTRAL PLATE | ELECTROSURGICAL PATIENT RETURN ELECTROD | ODR | ELLMAN INTERNATIONAL, INC. | IEC-NP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |