FDA Adverse Event
Malfunction
Summary report: N
MIDMARK
MDR report key: 19236642
·
Received May 3, 2024
Report
- Report Number
- 1523530-2024-00003
- Event Type
- Malfunction
- Date Received
- May 3, 2024
- Date of Event
- April 16, 2024
- Report Date
- May 3, 2024
- Manufacturer
- MIDMARK CORPORATION
- Product Code
- EAZ
- UDI-DI
- 00841709107405
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
SERVICE PARTS IDENTIFIED FOR DEVICE. MIDMARK CORPORATION BELIEVES THE ROOT CAUSE OF THIS EVENT IS SET UP ERROR.
Description of Event or Problem · 0
MIDMARK CORPORATION RECEIVED A COMPLAINT OF A DENTAL LIGHT HEAD POST OF A CEILING MOUNTED LED DENTAL LIGHT REPORTED TO HAVE COME LOOSE CAUSING THE POST, AND CONSEQUENTLY THE LIGHT, TO FALL. NO INJURY TO PATIENT OR STAFF WAS INVOLVED. DUE TO PREVIOUS REPORTING OF THIS OR SIMILAR INCIDENTS, MIDMARK CORPORATION COMPLIED TO REGULATORY REQUIREMENTS AND REPORTED THIS EVENT ACCORDINGLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1277650 | MIDMARK | LED DENTAL LIGHT | EAZ | MIDMARK CORPORATION | 153905-002 | 00841709107405 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |