MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-27 for MONDIAL 6 B1/R455 66016986 manufactured by Heraeus Kulzer Gmbh.
[20357417]
Spoke to technician at the lab. She said that the tooth broke while the patient was eating. The tooth #6-di portion broke. The patient did not notice it at the time and did not recover the piece. It is believed that she swallowed it. She did not notice the breakage till about an hour later due to the tooth surface feeling rough on her tongue. The patient had the denture approximately one month before the tooth broke. The patient has not reported recovering the tooth piece or had any intestinal issues. On (b)(6) 2013, spoke to technician. She said the patient is fine and they assume the tooth has passed. Mfr ref # 3006610834-2013-00014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1925223-2013-00115 |
| MDR Report Key | 3356823 |
| Date Received | 2013-08-27 |
| Date of Report | 2013-07-30 |
| Date Facility Aware | 2013-07-30 |
| Date Added to Maude | 2013-09-20 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 4315 SOUTH LAFAYETTE BLVD. |
| Manufacturer City | SOUTH BEND IN 466142517 |
| Manufacturer Country | US |
| Manufacturer Postal | 466142517 |
| Manufacturer G1 | HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION |
| Manufacturer Street | 4315 SOUTH LAFAYETTE BLVD. |
| Manufacturer City | SOUTH BEND IN 46614251 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46614 2517 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONDIAL 6 |
| Generic Name | ELM DENTURE, PLASTIC, TEETH |
| Product Code | ELM |
| Date Received | 2013-08-27 |
| Model Number | B1/R455 |
| Catalog Number | 66016986 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER GMBH |
| Manufacturer Address | WASSERBURG 88142 GM 88142 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-27 |