FDA Adverse Event
Injury
Summary report: N
HENRY SCHEIN
MDR report key: 20087020
·
Received August 28, 2024
Report
- Report Number
- 3007007357-2024-00023
- Event Type
- Injury
- Date Received
- August 28, 2024
- Date of Event
- June 18, 2024
- Report Date
- October 3, 2024
- Manufacturer
- TTBIO CORP
- Product Code
- EFB
- UDI-DI
- 00304040133682
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
HANDPIECES FELL APART WHILE BEING USED ON PATIENTS.
Description of Event or Problem · 0
HANDPIECES FELL APART WHILE BEING USED ON PATIENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 180823 | HENRY SCHEIN | HANDPIECE | EFB | TTBIO CORP | MAXIMA PRO 2L AR | 00304040133682 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |