MAUDE Adverse Event Report: GC AMERICA INC. COE-SOFT; RELINE MATERIAL

Catalog Number	344011
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Swelling (2091)
Date of Event	09/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No sample received from patient or dental provider.Evaluation based on retain sample.
Event or Problem Description
Gc america inc.(gca) received report mw5065490 from fda on 27 oct 2016.The patient had voluntarily reported an event through fda's medwatch program on 17 oct 2016.The patient reported the following symptoms after procedure at a dental provider with coe-soft, a reline material: mouth stinging, tongue swelling and stinging, lips sore, mouth red, blistery rash around mouth, head felt as if on fire, sinuses stinging, and loose, clear drainage.Gca was not aware of this event until after receiving the report.Gca called the patient back on 27 oct 2016 for follow up.The patient stated the name of their dental provider.The patient stated they were allergic to latex and were concerned about ingredients in coe-soft product.The patient stated they had an immediate denture placed on (b)(6) 2016 with a few teeth extracted.The patient stated they went back to their dental provider a week later with some sore ears in their mouth.The dental provider placed a reline material to help fit the dentures.The patient stated they had noticed a few small bits of reline on their face and rinsed it off at the dental provider's practice.The patient noticed a rash on their face the next day and also felt what was like a burning sensation in their sinus area.The patient stated that their throat, neck, and front of ears felt swollen as well as sore under their tongue.The patient went back to the dental provider last month and had the reline removed.The patient stated they felt as though their mouth was sore and that their sinus kept draining with swelling under tongue and in front of ears.The patient stated that their dental provider did not see anything when they came back, removed the reline, and suggested they see an ear, nose, and throat (ent) doctor.The patient gave permission to contact their dental provider.There was no additional information provided by the patient.Gca called the dental provider on 27 oct 2016 for follow up.The dental provider verified coe-soft was used and supplied the lot number.The dental provider stated they had used coe-soft correctly and worked well with previous patients.The dental provider stated there were no signs of a reaction, but did remove the reline material.The dental provider stated they did not believe the reline material was the cause and would follow up with the patient.There was no additional information provided by the dental provider.

• Brand Name: COE-SOFT
• Common Device Name: RELINE MATERIAL
• Manufacturer (Section D): GC AMERICA INC.; 3737 w. 127th st.; alsip IL 60803
• MDR Report Key: 6075774
• Report Number: 1410097-2016-00003
• Device Sequence Number: 19233016
• Product Code: EBI
• UDI-Device Identifier: D6583440111
• UDI-Public: D6583440111
• Combination Product (Y/N): N
• PMA/510(K) Number: K070697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/03/2016

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: 11/21/2018
• Device Catalogue Number: 344011
• Device Lot Number: 1511211
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2016
• Initial Report FDA Received Date: 11/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTURE
• Outcome Attributed to Adverse Event: Other