MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-01 for IPS EMPRESS CAD 602568 manufactured by Ivoclar Vivadent Ag.
[48715858]
Ingestion of foreign objects can occur at any time during dental procedures. Once a foreign object has reached the stomach it is expected that it will pass through the gastrointestinal tract as a result of peristalsis movement without complication, usually after a 7-10 day period. Follow up with patient on (b)(6) 2016 indicated improvement and pill camera procedure revealed evidence of healing. Patient reports ct scans, colonoscopy and endoscopy procedures conducted with no evidence of broken tooth piece found.
Patient Sequence No: 1, Text Type: N, H10
[48715859]
Patient swallowed portion of ips empress cad crown that had been placed on tooth #18 by the dentist on (b)(6) 2013. Patient returned to dentist on (b)(6) 2016 indicating that a piece of the crown was swallowed after eating almonds. The doctor confirmed that a portion of the patients crown fractured on the distolingual cusp. On (b)(6) 2016 the patient returned to the office claiming the portion of the crown swallowed caused pain and damage to his digestive system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612352-2016-00002 |
| MDR Report Key | 5765807 |
| Date Received | 2016-07-01 |
| Date of Report | 2016-07-01 |
| Date of Event | 2016-06-01 |
| Date Mfgr Received | 2016-06-02 |
| Date Added to Maude | 2016-07-01 |
| 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 | MS. DONNA HARTNETT |
| Manufacturer Street | 175 PINEVIEW DR. |
| Manufacturer City | AMHERST NY 14228 |
| Manufacturer Country | US |
| Manufacturer Postal | 14228 |
| Manufacturer Phone | 7166912260 |
| Manufacturer G1 | IVOCLAR VIVADENT AG |
| Manufacturer Street | BENDERERSTRASSE 2 |
| Manufacturer City | SCHAAN, 9494 |
| Manufacturer Country | LS |
| Manufacturer Postal Code | 9494 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IPS EMPRESS CAD |
| Generic Name | PORCELAIN/POWDER |
| Product Code | EIH |
| Date Received | 2016-07-01 |
| Catalog Number | 602568 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IVOCLAR VIVADENT AG |
| Manufacturer Address | BENDERERSTRASSE 2 SCHAAN, 9494 LS 9494 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-07-01 |