FDA Adverse Event
Malfunction
Summary report: Y
T1 LINE C 200 L
MDR report key: 15634981
·
Received October 19, 2022
Report
- Report Number
- 9614977-2022-00063
- Event Type
- Malfunction
- Date Received
- October 19, 2022
- Report Date
- October 19, 2022
- Manufacturer
- SIRONA DENTAL SYSTEMS GMBH
- Product Code
- EFB
- PMA / PMN Number
- K972436
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
1 OF 1 DEVICE WAS RETURNED FOR EVALUATION. THE EVALUATION OF 1 DEVICE HAS SHOWN THAT THE DEVICE WAS MANIPULATED AND RE-ASSEMBLED WITH A SPARE-PART (HEAD DRIVE INCLUSIVE BEARING AND CHUCK SYSTEM), WHICH WAS NOT MANUFACTURED BY SIRONA DENTAL SYSTEMS GMBH. THIS EVENT IS BEING SUBMITTED AS PART OF VMSR. ONLY ONE EVENT WAS RECEIVED FOR THIS DEVICE DURING THIS QUARTER.
Description of Event or Problem · 0
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT WHERE A T1 LINE HANDPIECE OVERHEATED. THE PATIENT EXPERIENCED A MINOR BURN, NO INTERVENTION WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2944792 | T1 LINE C 200 L | HANDPIECE, AIR-POWERED, DENTAL | EFB | SIRONA DENTAL SYSTEMS GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |