MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-22 for MERON APPLICATION CAPSULE REF 1243 manufactured by Voco Gmbh.
[136869110]
A product defect, as the cause of the problems described, is not detectable.
Patient Sequence No: 1, Text Type: N, H10
[136869111]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010908-2019-00003 |
| MDR Report Key | 8361393 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-22 |
| Date of Report | 2019-02-22 |
| Date of Event | 2019-02-08 |
| Device Manufacturer Date | 2018-07-09 |
| Date Added to Maude | 2019-02-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR MICHAEL CYLL |
| Manufacturer Street | ANTON-FLETTNER-STRASSE 1-3 |
| Manufacturer City | CUXHAVEN, NIEDERSACHSEN 27472 |
| Manufacturer Country | GM |
| Manufacturer Postal | 27472 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERON APPLICATION CAPSULE |
| Generic Name | GLASS IONOMER LUTING CEMENT |
| Product Code | EMA |
| Date Received | 2019-02-22 |
| Returned To Mfg | 2019-02-12 |
| Model Number | REF 1243 |
| Lot Number | 1841535 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VOCO GMBH |
| Manufacturer Address | ANTON-FLETTNER-STRASSE 1-3 CUXHAVEN, NIEDERSACHSEN 27472 GM 27472 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-22 |