FDA Adverse Event
Malfunction
Summary report: N
SUREFLEX ENDO FILE
MDR report key: 34947
·
Received August 2, 1996
Report
- Report Number
- MW1009627
- Event Type
- Malfunction
- Date Received
- August 2, 1996
- Report Date
- July 23, 1996
- Manufacturer
- DENTSPLY INTL., INC.
- Product Code
- EKS
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MT, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
ENDODONTIC FILE LABELED 21 MM BUT CONTAINS 25 MM LENGTH FILES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUREFLEX ENDO FILE | ENDODONTIC FILE | EKS | DENTSPLY INTL., INC. | 664005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |