FDA Adverse Event Injury Summary report: N

COE-SOFT 5.5 OZ PROFESSIONAL PACKAGE

MDR report key: 6605335 · Received June 1, 2017

Report

Report Number: 1410097-2017-00002
Event Type: Injury
Date Received: June 1, 2017
Date of Event: March 27, 2017
Report Date: June 1, 2017
Manufacturer: GC AMERICA INC.
Product Code: EBI
UDI-DI: D6583440111
PMA / PMN Number: K0770697
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

Description of Event or Problem · 1

GC AMERICA INC. (GCA) RECEIVED REPORT MW5068722 FROM FDA'S MEDWATCH PROGRAM ON 20 APR 2017. THE PATIENT WAS PRESENT AT A DENTAL OFFICE AND UNDER THE CARE OF A FEMALE DENTIST. WHEN AT OR SHORTLY AFTER 3 PM, THE DENTIST APPLIED A DENTAL PRODUCT KNOWN AS THE BRAND-NAME "COE-SOFT" USED AS A TEMPORARY DENTURE LINER. THE PATIENT EXPERIENCED THE FOLLOWING SYMPTOMS: SINUS INFLAMMATION, ADRENALINE RUSH, FAST HEART RATE (POUNDING HEART), THROAT SCRATCHINESS AND STIFFNESS WITH DIFFICULTY SWALLOWING, TIGHTNESS IN THE CHEST, AND INABILITY TO TAKE A FULL BREATH. THE PATIENT INSTRUCTED THE DENTIST TO CALL 911 FOR THE ALLERGIC REACTION. 'NAME WITHHELD' RESPONDED BECAUSE AN AMBULANCE WAS NOT CLOSE ENOUGH. THE AMBULANCE ARRIVED AND TRANSPORTED THE PATIENT TO A HOSPITAL WHERE TREATMENT WAS STARTED AND COMPLETED WITH 50 MG OF BENADRYL BY MOUTH, 40 MG OF PREDNISONE BY MOUTH, 10 MG OF FAMOTIDINE BY MOUTH. SYMPTOMS TOOK 4 TO 4.5 HOURS TO SUBSIDE ONCE TREATMENT WAS STARTED. NO ADDITIONAL INFORMATION WAS OBTAINED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
387475	COE-SOFT 5.5 OZ PROFESSIONAL PACKAGE	DENTURE RELINE	EBI	GC AMERICA INC.			D6583440111

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization