MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-18 for IVOCAP PREFERENCE 602164 manufactured by Ivoclar Vivadent Ag.
[130775514]
On (b)(6) 2018, a dentist reported that a patient was hospitalized on (b)(6) 2018 after experiencing anaphylactic shock. The doctor confirmed the patient had been a denture wearer and presented with existing full upper and lower dentures. The insertion of new dentures was on (b)(6) 2019. The patient was seen at a follow-up appointment on (b)(6) 2018, at this appointment an adjustment was made and oral examination showed pink, healthy tissue. The dentist was not aware of any history of allergy to any of the materials utilized in this case and suspects the reaction that occured on (b)(6) is unrelated to the denture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612352-2018-00002 |
| MDR Report Key | 8175422 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-18 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-11-06 |
| Date Added to Maude | 2018-12-18 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LORI ALESHIN |
| Manufacturer Street | 175 PINEVIEW DRIVE |
| Manufacturer City | AMHERST NY 14228 |
| Manufacturer Country | US |
| Manufacturer Postal | 14228 |
| Manufacturer Phone | 7162642045 |
| Manufacturer G1 | IVOCLAR VIVADENT AG |
| Manufacturer Street | BENDERERSTRASSE 2 |
| Manufacturer City | SCHAAN, LI 9494 |
| Manufacturer Country | LS |
| Manufacturer Postal Code | 9494 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IVOCAP PREFERENCE |
| Generic Name | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
| Product Code | EBI |
| Date Received | 2018-12-18 |
| Catalog Number | 602164 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IVOCLAR VIVADENT AG |
| Manufacturer Address | BENDERERSTRASSE 2 SCHAAN, LI 9494 LS 9494 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-12-18 |