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

Catalog Number	H09105
Health Effect - Clinical Code	Reaction (2414)
Type of Reportable Event	Serious Injury
Event or Problem Description
An allergic reaction occured after an office visit following the use of a non-latex dental dam.
Additional 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
• Common Device Name: DENTAL DAM
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• MDR Report Key: 8731711
• Report Number: 2416455-2019-00002
• Device Sequence Number: 2021877
• Product Code: EIE
• UDI-Device Identifier: D661H091051
• UDI-Public: D661H091051
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: H09105
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other