inforMED
MalfunctionEAT

TOUCH N' HEAT

Received Aug 26, 2013

Report 2016150-2013-00101 · MDR key 3307072

Device

Generic name

Pulp Tester

Manufacturer

Sybronendo

Catalog number

973-0212

Product problems

  • Overheating of Device

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

A DOCTOR'S OFFICE HAD ALLEGED THAT TWO (2) TOUCH N' HEAT UNITS HAD CONTINUED HEATING UP WHEN NOT IN USE AND PLUGGED IN. THIS IS THE SECOND OF TWO (2) REPORTS.

Additional Manufacturer Narrative

NO FURTHER INFORMATION WAS RECEIVED WITH REGARD TO THIS INCIDENT. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE COMPLAINANT IN ORDER TO OBTAIN FURTHER INFORMATION; HOWEVER, THE COMPLAINANT HAS REMAINED UNRESPONSIVE. AN UPDATE WILL BE PROVIDED IF ANY NEW INFORMATION BECOMES AVAILABLE. A VISUAL AND PHYSICAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT A SPRING WAS BENT ON THE DEVICE, CAUSING CONSTANT HEATING.