MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-11-28 for IPS CONTRAST SPRAY CHAIRSIDE 50ML 614435AN manufactured by Ivoclar Vivadent Ag.
[2402086]
Patient claims she experienced a major asthmatic attack after treatment with contrast spray chairside and required a trip to the hospital.
Patient Sequence No: 1, Text Type: D, B5
[9596524]
Complaint was investigated and clinician indicated that the patient was not experiencing any symptoms when she left the office and appeared to be fine. She never reported that she had asthma during her medical exam. Patient was heavy set that also might cause difficulties breathing. Patient is reported to have fully recovered. The product msds includes information regarding the contents as well as respiratory precautions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612352-2011-00008 |
| MDR Report Key | 2394900 |
| Report Source | 05 |
| Date Received | 2011-11-28 |
| Date of Report | 2011-11-23 |
| Date of Event | 2011-10-20 |
| Date Mfgr Received | 2011-10-20 |
| Date Added to Maude | 2012-01-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 175 PINEVIEW DRIVE |
| Manufacturer City | AMHERST NY 14228 |
| Manufacturer Country | US |
| Manufacturer Postal | 14228 |
| Manufacturer Phone | 7166912260 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NONE |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IPS CONTRAST SPRAY CHAIRSIDE 50ML |
| Generic Name | ACCESSORY TO OPTICAL IMPRESSION SYSTEM |
| Product Code | NOF |
| Date Received | 2011-11-28 |
| Model Number | 614435AN |
| Lot Number | ML8503 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IVOCLAR VIVADENT AG |
| Manufacturer Address | SCHAAN LS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-11-28 |