Additional Manufacturer Narrative · 1
A REVIEW OF OUR COMPLAINT DATABASE UNCOVERED NO SIMILAR COMPLAINTS OR MDRS REGARDING THE SUBJECT DEVICE; HOWEVER, THREE MDRS WERE FILED WITH REGARDS TO SIMILAR PRODUCTS, I.E. INFANT HEEL WARMERS (REFERENCE LIST ATTACHED). THE TRANSPORT MATTRESS AND THE HEEL WARMER BOTH CONTAIN THE SAME SOLUTION, FOOD GRADE SODIUM ACETATE, WATER AND THICKENERS. THESE PREVIOUS EVENTS ARE NOT SIMILAR IN NATURE TO THE SUBJECT EVENT, THEREFORE, THE SUBJECT EVENT IS NOT CONSIDERED PART OF A TREND. THERE HAVE BEEN NO DESIGN CHANGES SINCE THIS PRODUCT WAS MARKETED RELATING TO THIS EVENT. ONCE ACTIVATED, THE TRANSPORT MATTRESS IS EXPECTED TO PROVIDE HEAT FOR UP TO TWO HOURS. THERE ARE NO COMPLAINTS INDICATING THE MATTRESS FAILED TO STAY WARM FOR THE ANTICIPATED TWO HOURS. WITH REGARDS TO THIS EVENT, THE INSTRUCTIONS FOR USE, LOCATED ON THE DEVICE, IN STATEMENT 6 STATES TO CHECK THE INFANT'S SKIN OCCASIONALLY FOR REDNESS AND CORE TEMPERATURE. THE 0TRANSPORT MATTRESS WAS USED IN CONJUNCTION WITH EXTERNAL HEAT SOURCES.