MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-12-07 for HYDENT ARTICULATION PASTE 05100 manufactured by Pascal Co., Inc..
[2524390]
Patient reported experiencing symptoms of vomiting, diarrhea, cold sweats, dizziness, and loss of consciousness (less than 1 minute) several hours after being administered hydent, an aerosol denture articulation paste. The patient reported experiencing symptoms after each administration, with the second administration producing more severe symptoms than the first. The patient sought medical attention several days after the last appearance of the symptoms. Please note: this is a re-submission of the original report sent (b)(4) 2011.
Patient Sequence No: 1, Text Type: D, B5
[9718471]
Contents of hydent: soybean oil, zinc oxide, mint flavor, aerosol propellant.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3011632-2011-00004 |
| MDR Report Key | 2466205 |
| Report Source | 07 |
| Date Received | 2011-12-07 |
| Date of Report | 2012-02-21 |
| Date of Event | 2011-11-16 |
| Date Mfgr Received | 2011-11-30 |
| Date Added to Maude | 2012-02-27 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | VINCENT TENTARELLI |
| Manufacturer Street | 2929 N.E. NORTHUP WAY |
| Manufacturer City | BELLEVUE WA 98004 |
| Manufacturer Country | US |
| Manufacturer Postal | 98004 |
| Manufacturer Phone | 4256023633 |
| 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 | 2011-12-07 |
| Model Number | NA |
| Catalog Number | 05100 |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PASCAL CO., INC. |
| Manufacturer Address | 2929 N.E. NORTHUP WAY BELLEVUE WA 98004 US 98004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-12-07 |