MAUDE Adverse Event Report: COLTENE WHALEDENT INC. HYGENIC WAX; WHITE WAX ROPES SQUARE

Catalog Number H00820

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 10/27/2023

Event Type  Injury  

Event Description

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.

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.

• Brand Name: HYGENIC WAX
• Type of Device: WHITE WAX ROPES SQUARE
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• Manufacturer (Section G): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• Manufacturer Contact: tricia cregger ; 235 ascot parkway; cuyahoga falls, OH 44223
• MDR Report Key: 18430085
• MDR Text Key: 331789041
• Report Number: 2416455-2023-00001
• Device Sequence Number: 1
• Product Code: EGD
• UDI-Device Identifier: 0+D661H0082019
• UDI-Public: +D661H0082019
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: H00820
• Device Lot Number: K80917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 12/01/2023
• Supplement Dates FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female