FDA Adverse Event
Injury
Summary report: N
SONICFILL COMPOSITE
MDR report key: 3960550
·
Received July 28, 2014
Report
- Report Number
- 2024312-2014-00526
- Event Type
- Injury
- Date Received
- July 28, 2014
- Report Date
- July 7, 2014
- Manufacturer
- KERR CORPORATION
- Product Code
- EBF
- PMA / PMN Number
- K091023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
SPECIFIC PATIENT INFORMATION WITH REGARD TO GENDER, AGE AND WEIGHT WAS NOT PROVIDED. THE DOCTOR REMOVED THE SONICFILL RESTORATION AND REPEATED THE PROCEDURE USING A DIFFERENT PRODUCT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.
Description of Event or Problem · 1
A DOCTOR ALLEGED THAT APPROXIMATELY TEN (10) PATIENTS HAD EXPERIENCED THE REPLACEMENT OF A SONICFILL RESTORATION DUE TO MICROLEAKAGE. THIS IS THE NINTH OF TEN (10) REPORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 439654 | SONICFILL COMPOSITE | TOOTH SHADE RESIN MATERIAL | EBF | KERR CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |