FDA Adverse Event
Injury
Summary report: N
MERON APPLICATION CAPSULE
MDR report key: 8361393
·
Received February 22, 2019
Report
- Report Number
- 8010908-2019-00003
- Event Type
- Injury
- Date Received
- February 22, 2019
- Date of Event
- February 8, 2019
- Report Date
- February 22, 2019
- Manufacturer
- VOCO GMBH
- Product Code
- EMA
- PMA / PMN Number
- K130421
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
A PRODUCT DEFECT, AS THE CAUSE OF THE PROBLEMS DESCRIBED, IS NOT DETECTABLE.
Description of Event or Problem · 1
DURING A VISIT BY OUR SALES REPRESENTATIVE, THE DENTIST CLAIMED THAT HE HAS HAD SEVERAL PROBLEMS AFTER THE DEFINITIVE INSERTION OF RESTORATIONS ON VITAL TEETH. SOME PATIENTS HAD COMPLAINED ABOUT PULP IRRITATIONS, HYPERSENSITIVITIES OR BITE SENSITIVITY (DESPITE GOOD OCCLUSION). THE RESTORATIONS WERE REMOVED AS A PRECAUTIONARY MEASURE AND INITIALLY PROVISIONALLY RESTORED. THE SYMPTOMS THEN IMMEDIATELY SUBSIDED. THE FURTHER TREATMENT WAS CARRIED OUT WITHOUT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 157178 | MERON APPLICATION CAPSULE | GLASS IONOMER LUTING CEMENT | EMA | VOCO GMBH | REF 1243 | 1841535 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |