FDA Adverse Event
Injury
Summary report: N
HYDENT ARTICULATION PASTE
MDR report key: 2466205
·
Received December 7, 2011
Report
- Report Number
- 3011632-2011-00004
- Event Type
- Injury
- Date Received
- December 7, 2011
- Date of Event
- November 16, 2011
- Report Date
- February 21, 2012
- Manufacturer
- PASCAL CO., INC.
- Product Code
- EFH
- PMA / PMN Number
- K911259
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CONTENTS OF HYDENT: SOYBEAN OIL, ZINC OXIDE, MINT FLAVOR, AEROSOL PROPELLANT.
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYDENT ARTICULATION PASTE | DENTURE ARTICULATION AEROSOL PASTE | EFH | PASCAL CO., INC. | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other | NONE KNOWN |