FDA Adverse Event
Injury
Summary report: N
HENRY SCHEIN, MAXIMA ELITE
MDR report key: 19759695
·
Received July 17, 2024
Report
- Report Number
- 3011300255-2024-00004
- Event Type
- Injury
- Date Received
- July 17, 2024
- Date of Event
- May 14, 2024
- Report Date
- September 19, 2024
- Manufacturer
- W&H DENTALWERK BUERMOOS GMBH,
- Product Code
- EFB
- UDI-DI
- 00304040153857
- PMA / PMN Number
- K162926
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
RELATED REPORT NUMBER 3007007357-2024-00018.
Additional Manufacturer Narrative · 0
RELATED REPORT NUMBER 3007007357-2024-00018. NO INVESTIGATION COULD BE CARRIED OUT, BECAUSE THE HANDPIECE WAS NOT RETURNED. THE DEVICE COMPLAINT OR PROBLEM CANNOT BE CONFIRMED.
Additional Manufacturer Narrative · 0
RELATED REPORT NUMBER 3007007357-2024-00018. NO INVESTIGATION COULD BE CARRIED OUT, BECAUSE THE HANDPIECE WAS NOT RETURNED. THE DEVICE COMPLAINT OR PROBLEM CANNOT BE CONFIRMED.
Description of Event or Problem · 0
THE CUSTOMER DESCRIBED THE HANDPIECES ARE STILL HAVING OVERHEATING ISSUES.
Description of Event or Problem · 0
THE CUSTOMER DESCRIBED THE HANDPIECES ARE STILL HAVING OVERHEATING ISSUES.
Description of Event or Problem · 0
THE CUSTOMER DESCRIBED THE HANDPIECES ARE STILL HAVING OVERHEATING ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 739370 | HENRY SCHEIN, MAXIMA ELITE | HANDPIECE | EFB | W&H DENTALWERK BUERMOOS GMBH, | MAXIMA ELITE 2 1:5 | 00304040153857 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |