HYGENIC WAX
Received Jan 2, 2024 · Event occurred Oct 27, 2023
Report 2416455-2023-00001 · MDR key 18430085
Device
Generic name
White Wax Ropes Square
Manufacturer
Coltene Whaledent Inc.Catalog number
H00820
Lot number
K80917
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Hypersensitivity/Allergic reaction
- Hypersensitivity/Allergic reaction
Narrative
Description of Event or Problem
ONE OF THEIR HYGIENISTS HAD AN ALLERGIC REACTION TO THE WAX. SHE IS HIGHLY ALLERGIC TO BEESWAX. EPI PEN WAS ADMINISTERED AND SHE WAS SENT TO AN URGENT CARE OFFICE, SHE WAS HOSPITALIZED AND INTUBATED LATER THAT DAY FOR 3 DAYS.
Additional Manufacturer Narrative
DEVICE EVALUATION: THE WAX WAS RETURNED FOR INVESTIGATION. THIS WAX IS NOT MADE WITH BEESWAX AND THERE ARE NO CURRENT PRODUCTS MADE AT COLTENE WITH BEESWAX. IT WAS SENT TO THE RAW MATERIAL SUPPLIER FOR TESTING. THIS WAX IS A MICROCRYSTALLINE WAX BLEND, WHICH IS A CLASS OF CHEMICALS THAT INCLUDE PARAFFIN WAXES AND HYDROCARBON WAXES. TESTING ON THE PRODUCT CONFIRMED THAT IT CONTAINS NO BEESWAX AND THERE WAS NO BEESWAX CONTAMINATION. NO ISSUE WAS IDENTIFIED WITH THE WAX RETURNED FROM THE CUSTOMER.