MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-05 for TELIO CS LINK 627941AN manufactured by Ivoclar Vivadent Ag.
[56540131]
The dentist reports that 6-7 patients as well as 2 staff members complain of severe sensitivity after using the cement. There were several patients in which the cement was used as well however with no reaction. Each patient showed a pulpal reaction to the cement. In each complaint case, the patient complained of a lot of pain. A total of 3 complaints were received: (b)(4) from the same dentist. Only one patient resulted in a root canal therapy recommended by a different/new dentist. In the other patients the pain ceased once the provisional restoration and cement was replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612352-2016-00005 |
| MDR Report Key | 6001542 |
| Date Received | 2016-10-05 |
| Date of Report | 2016-08-17 |
| Date of Event | 2015-03-04 |
| Date Mfgr Received | 2015-03-05 |
| Date Added to Maude | 2016-10-05 |
| 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 DRIVE |
| Manufacturer City | AMHERST 14228 |
| Manufacturer Country | US |
| Manufacturer Postal | 14228 |
| Manufacturer Phone | 7162912260 |
| 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 | TELIO CS LINK |
| Generic Name | CEMENT, DENTAL |
| Product Code | EMA |
| Date Received | 2016-10-05 |
| Returned To Mfg | 2015-03-04 |
| Catalog Number | 627941AN |
| Lot Number | T35331 |
| Device Expiration Date | 2015-08-29 |
| Operator | DENTIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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. Other | 2016-10-05 |