MAUDE Adverse Event Report: COLTENE WHALEDENT INC. HYGENIC; DENTAL DAM

Catalog Number H09105

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

Patient Problem Reaction (2414)

Event Type  Injury  

Event Description

An allergic reaction occured after an office visit following the use of a non-latex dental dam.

Manufacturer Narrative

On 6/27/2019 coltene was made aware that the product involved in the adverse event was not a coltene product.This medical device report can be voided.

• Brand Name: HYGENIC
• Type of Device: DENTAL DAM
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• MDR Report Key: 8731711
• MDR Text Key: 149122835
• Report Number: 2416455-2019-00002
• Device Sequence Number: 1
• Product Code: EIE
• UDI-Device Identifier: D661H091051
• UDI-Public: D661H091051
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: H09105
• Date Manufacturer Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other