FDA Adverse Event
Injury
Summary report: N
BREEZE SELF-ETCH CEMENT
MDR report key: 2506504
·
Received March 27, 2012
Report
- Report Number
- 2024312-2012-00043
- Event Type
- Injury
- Date Received
- March 27, 2012
- Date of Event
- February 24, 2012
- Report Date
- February 27, 2012
- Manufacturer
- PENTRON CLINICAL
- Product Code
- EMA
- PMA / PMN Number
- K060698
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE PATIENT HAD TO RETURN TO HAVE THE CROWN REPLACED. IT WAS CONFIRMED WITH THE DOCTOR'S OFFICE THAT THE DOCTOR RE-CEMENTED THE CROWN WITH A DIFFERENT BATCH OF THE SAME PRODUCT WITHOUT FURTHER INCIDENT. THE PATIENT IS DOING FINE. AN EVALUATION OF THE RETURNED PRODUCT WAS PERFORMED FOR ADHESIVE STRENGTH AND THE PRODUCT WAS WITHIN SPECIFICATIONS.
Description of Event or Problem · 1
A DOCTOR ALLEGED THAT ONE OF HIS PATIENTS EXPERIENCED A LOOSE CROWN WITHIN THREE DAYS OF PLACEMENT USING BREEZE SELF-ETCH CEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BREEZE SELF-ETCH CEMENT | DENTAL CEMENT | EMA | PENTRON CLINICAL | 3673217 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |