MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-10-30 for MONDIAL 6 BL2 / L315 66801038 manufactured by Heraeus Kulzer Gmbh.
[3732181]
Lab rep called and said that the complete removable denture was delivered on (b)(6) 2012. She said that it was a lower anterior tooth. She did not know which tooth, mold or shade it was, but said she would ask the lab guys. She said that she does not think the pt swallowed any of the tooth and would check to see if they have the fragments. She said the pt was very angry that she had to pay for the repair. She said that they believe the pt was eating and bit into something very hard. She did not know the pt's age. On (b)(6) 2013 lab rep called and gave the mould and shade. She said that tooth number 24 broke. They do not have the broken off part and the part that remained in the denture was destroyed to remove. Ref mfr 3006610834-2013-00017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1925223-2013-00155 |
| MDR Report Key | 3450023 |
| Report Source | 99 |
| Date Received | 2013-10-30 |
| Date of Report | 2013-10-04 |
| Date Facility Aware | 2013-10-04 |
| Date Added to Maude | 2013-11-06 |
| 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 | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONDIAL 6 |
| Generic Name | ELM DENTURE, PLASTIC, TEETH |
| Product Code | ELM |
| Date Received | 2013-10-30 |
| Model Number | BL2 / L315 |
| Catalog Number | 66801038 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2013-10-30 |