MGARD SOF-TRAY SHEETS (226)

Report

Report Number: 1718912-2011-00001
Event Type: Other
Date Received: January 10, 2011
Date of Event: December 3, 2010
Report Date: January 7, 2011
Manufacturer: MANUFACTURED FOR ULTRADENT BY UNIVERSAL PLASTICS
Product Code: BRW
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE LC BLOCKOUT RESIN IFU CONTAINS A PRECAUTION/WARNING ABOUT THE POTENTIAL FOR SENSITIZATION WHEN HANDLING METHACRYLATE-BASED RESINS, AND MENTIONS 'IF ALLERGIC REACTION, DERMATITIS OR RASH DEVELOPS, CONSULT A PHYSICIAN.'

Description of Event or Problem · 1

THE ADVERSE EVENT OCCURRED AT A (B)(6) DURING A MFR-SPONSORED, HANDS-ON LECTURE. DURING THE TRAY FABRICATION EXERCISE, A FEMALE (B)(6) BECAME LIGHT-HEADED, FLUSHED AND FELT LIKE SHE WAS GOING TO PASS OUT. FOUR VACUUM FORMER MACHINES WERE RUNNING AT THE TIME, AND ALL WERE USING TRAY SHEETS AND LC BLOCKOUT RESIN DURING THIS TIME. THE FUMES WERE NOTICEABLE IN THE ROOM FROM THESE ACTIVITIES. THE (B)(6) WAS TAKEN TO THE CLINICAL AREA AND A WET RAG PLACED ON THE BACK OF HER NECK. HER HEART WAS RACING, SO PARAMEDICS WERE CALLED. THE STUDENT'S BP WAS 156/90 AND HER PULSE WAS 116. THE STUDENT WAS TAKEN TO (B)(6) AND RELEASED IN THE EVENING. THE ON-CALL PHYSICIAN BELIEVES THE REACTION WAS CAUSED BY THE FUMES IN THE ROOM. A WEEK LATER, THE STUDENT HAD A SIMILAR REACTION WHILE SHE WAS TRIMMING TRAYS (THIS IS DONE AFTER LC BLOCKOUT RESIN AND VACUUM FORMING HAS BEEN DONE). THIS REACTION WAS LESS SEVERE, BUT THE STUDENT DID LEAVE CLASS TO PURCHASE AND TAKE BENADRYL. THE STUDENT FELT FINE 20 MINS LATER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MGARD SOF-TRAY SHEETS (226)	SOF-TRAY CLASSIC SHEETS (0.035")	BRW	MANUFACTURED FOR ULTRADENT BY UNIVERSAL PLASTICS	226

Patients

Seq	Age	Sex	Outcome	Treatment
1	23 YR		Hospitalization	LC BLOCKOUT\| VACUUM FORMER