MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-12 for MERON APPLICATION CAPSULE REF 1243 manufactured by Voco Gmbh.
[135888887]
The testing of the manufacturing and release documentation did not reveal any deviations. Contact was made with the dentist in charge in order to clarify possible causes of the problems. A clear cause could not be identified. A product defect, as the cause of the problems described, is not identified.
Patient Sequence No: 1, Text Type: N, H10
[135888888]
A dentist complained that he had been having problems using meron application capsules since about 4 weeks. In at least 15 cases, patients complained of pain one day after the restoration was inserted. In at least 10 cases an endodontic treatment had been carried out. Details on the patients and the individual treatment procedures are not available. Various crowns and bridges were attached.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010908-2019-00001 |
| MDR Report Key | 8331504 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-12 |
| Date of Report | 2019-02-12 |
| Date of Event | 2019-01-28 |
| Date Mfgr Received | 2019-01-28 |
| Device Manufacturer Date | 2018-03-23 |
| Date Added to Maude | 2019-02-12 |
| 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 | 2019-02-12 |
| Returned To Mfg | 2019-02-01 |
| Model Number | REF 1243 |
| Lot Number | 1826554 |
| 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. Other | 2019-02-12 |