FDA Adverse Event
Malfunction
Summary report: N
PROULTRA ENDO TIPS
MDR report key: 720874
·
Received May 26, 2006
Report
- Report Number
- 2029155-2006-00190
- Event Type
- Malfunction
- Date Received
- May 26, 2006
- Date of Event
- April 27, 2006
- Report Date
- April 27, 2006
- Manufacturer
- DENTSPLY TULSA
- Product Code
- ELC
- PMA / PMN Number
- K960889
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
A PROFILE ENDO TIP SEPERATED THE SEPERATED PIECE WAS RETRIEVED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROULTRA ENDO TIPS | ELC | ELC | DENTSPLY TULSA | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |