InjuryKOQ
EQUATE DENTURE ADHESIVE
Received Sep 26, 2014 · Event occurred Oct 31, 2013
Report 1210513-2014-00002 · MDR key 4173289
Device
Generic name
Denture Adhesive
Manufacturer
Sheffield PharmaceuticalsProduct problems
- Device Emits Odor
- Patient-Device Incompatibility
Patient
60 YR
- Nausea
- Vomiting
Narrative
Description of Event or Problem
THE PT/REPORTER CLAIMED THAT EQUATE DENTURE ADHESIVE, AFTER SHE USED IT FOR THE FIRST TIME, MADE HER NAUSEATED AND VOMIT. IN ADDITION, THE PRODUCT ALSO HAD A BAD SMELL.
Additional Manufacturer Narrative
RESERVE SAMPLE (30711) WITH THE SAME LOT AS THE SUSPECT SAMPLE WAS TESTED FOR TOTAL AEROBIC PLATE COUNT AND ATTRIBUTES. NO ISSUES WERE IDENTIFIED WITH THE TEST RESULTS.