MAUDE Adverse Event Report: GC AMERICA INC. EXA'LENCE REGULAR HEAVY 48 ML; IMPRESSION MATERIAL

Catalog Number	137004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient did have a known allergy to mint.The dentist had an impression material that they knew had a mint in it and couldn't use and decided to use exa'lence instead.The dentist was unaware that exa'lence had any mint flavor in it because they could not find any information on the box.After the patient left the office, she contacted the dentist office via email informed that she was experiencing respiratory like symptoms and contacted her physician.The dentist ofiice stated that the patient took benadryl and it alleviated the problem and she is fine at this time.
Additional Manufacturer Narrative
We will review instructions for use of the device to improve the information on potential allergens.
Event or Problem Description
The patient did have a known allergy to mint.The dentist had an impression material that they knew had a mint in it and couldn't use and decided to use exa'lence instead.The dentist was unaware that exa'lence had any mint flavor in it because they could not find any information on the box.After the patient left the office, she contacted the dentist office via email informed that she was experiencing respiratory like symptoms and contacted her physician.The dentist ofiice stated that the patient took benadryl and it alleviated the problem and she is fine at this time.

• Brand Name: EXA'LENCE REGULAR HEAVY 48 ML
• Common Device Name: IMPRESSION MATERIAL
• Manufacturer (Section D): GC AMERICA INC.; 3737 w. 127th street; alsip IL 60803
• MDR Report Key: 7301236
• Report Number: 1410097-2018-00001
• Device Sequence Number: 1342992
• Product Code: ELW
• UDI-Device Identifier: D6581370041
• UDI-Public: D6581370041
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K041398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Dentist
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2018
• Report Date (Section F): 03/05/2018

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: Dentist
• Device Expiration Date: 03/29/2019
• Device Catalogue Number: 137004
• Device Lot Number: 1609291
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/01/2018
• Device Age: 2 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/01/2018
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 03/05/2018
• 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; Required Intervention
• Date Report Sent to FDA: 03/05/2018