MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2015-07-21 for HYDENT ARTICULATION PASTE N/A 05-100 manufactured by Pascal Company, Inc..
[6055741]
On (b)(6) 2015, pascal received a call from the spouse of patient who experienced symptoms commonly associated with a heart attack approximately 1 hour after undergoing a denture fitting on (b)(6) during which hydent, pascal's occusal spray was used. The symptoms included pain in lower rib cage, shortness of breath, cold sweat, dry heaves, tightening of chest. The purpose of the call was to discover the ingredients of hydent to determine if any component may have contributed to the symptoms. Because patient wears a pacemaker, he went to the emergency room, where doctors determined he did not experience a heart attack after performing a variety of tests, including an ekg. The er physician administered low-dose aspirin and nitroglycerin. He was discharged and the symptoms subsided about 1 hour after leaving hospital. The spouse indicated that the patient was allergic to topical analgesics. I asked the dentist if they applied any topical gels, and she said they did not. The dentist indicated that the patient seemed agitated upon arrival to the clinic, and became more so when told he had to sit in the dental chair for the fitting. The dentist stated that the patient wanted to remain standing during the fitting. No reason was given by the patient. On (b)(6) the results of a stress test were normal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011632-2015-00001 |
| MDR Report Key | 4929870 |
| Report Source | 00 |
| Date Received | 2015-07-21 |
| Date of Report | 2015-07-21 |
| Date of Event | 2015-06-16 |
| Date Mfgr Received | 2015-06-16 |
| Device Manufacturer Date | 2014-05-23 |
| Date Added to Maude | 2015-07-22 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. VINCE TENTARELLI |
| Manufacturer Street | 2929 NE NORTHUP WAY |
| Manufacturer City | BELLEVUE WA 98004 |
| Manufacturer Country | US |
| Manufacturer Postal | 98004 |
| Manufacturer Phone | 4256023633 |
| Manufacturer G1 | PASCAL COMPANY, INC. |
| Manufacturer Street | 2929 NE NORTHUP WAY |
| Manufacturer City | BELLEVUE WA 98004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYDENT ARTICULATION PASTE |
| Generic Name | DENTURE ARTICULATION AEROSOL PASTE |
| Product Code | EFH |
| Date Received | 2015-07-21 |
| Model Number | N/A |
| Catalog Number | 05-100 |
| Lot Number | 050117 |
| Device Expiration Date | 2017-05-31 |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PASCAL COMPANY, INC. |
| Manufacturer Address | 2929 NE NORTHUP WAY BELLEVUE WA 98004 US 98004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-21 |