MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-25 for MONDIAL 66016910 manufactured by Kulzer Gmbh.
[87298676]
(b)(4). Although we have not established the device caused or contributed to the event, the incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[87298677]
Patient complains of vague allergy symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006610834-2017-00001 |
| MDR Report Key | 6891932 |
| Date Received | 2017-09-25 |
| Date of Report | 2017-09-07 |
| Date Facility Aware | 2017-09-07 |
| Date Mfgr Received | 2017-09-07 |
| Date Added to Maude | 2017-09-25 |
| 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 | RITA ROGERS |
| Manufacturer Street | 4315 LAFAYETTE BLVD |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer G1 | KULZER GMBH |
| Manufacturer Street | SCHLATTEREST 2 |
| Manufacturer City | WASSERBURG, BAYERN 88142 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 88142 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MONDIAL |
| Generic Name | DENTURE, PLASTIC, TEETH |
| Product Code | ELM |
| Date Received | 2017-09-25 |
| Catalog Number | 66016910 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KULZER GMBH |
| Manufacturer Address | SCHLATTEREST 2 WASSERBURG, BAYERN 88142 GM 88142 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-25 |