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BRAND NAMEDAVOL HOSPITAL HEATING PAD
DAVOL, INC.
P.O. BOX 8500
CRANSTON RI 02920
ACCESS NUMBERM712171
PRODUCT CODEIRT
PANELPHYSICAL MEDICINE
REPORT TYPESERIOUS INJURY
DATE FDA RECEIVED05/23/1995
DEVICE CATALOGUE NUMBER310
EVENT DESCRIPTION TYPEFINAL
EVENT DESCRIPTION
A PT WAS BURNED WHILE THE HEATING PAD WAS BEING USED. A REPORT WAS RECIEVED THAT STATED A PT WAS BURNED WHILE HEATING PAD WAS BEING USED. 06/09/95-NO FURTHER INFO HAS BEEN RECEIVED REGARDING THE ABOVE NOTED OCCURRENCE. THERE ARE NUMEROUS IMPORTANT SAFETY INSTRUCTIONS CONTAINED BOTH ON THE HEATING PAD BOX, AND PRINTED DIRECTLY ON THE PAD ITSELF. SOME OF THE INSTRUCTIONS INCLUDE: DO NOT USE WHILE SLEEPING; THIS PAD IS NOT TO BE USED BY OR AN INVALID, A SLEEPING OR UNCONSCIOUS PERSON, OR A PERSON WITH POOR BLOOD CIRCULATION; DO NOT USE THE PAD ON AREAS OF SENSITIVE SKIN; CHECK THE PAD FREQUENTLY TO AVOID BURNING OR BLISTERING; CAREFULLY EXAMINE THIS COVER BEFORE EACH USE. DISCARD PAD IF THE COVERING SHOWS ANY SIGNS DETERIORATION (SUCH AS BLISTERING); PLACE THE PAD ON TOP OF AND NOT UNDER THE PART OF THE BODY NEEDING HEAT ETC. THIS IS A LEGAL MATTER AND, AS SUCH, IS BEING HANDLED THROUGH OUR LEGAL DEPT. IF ANY FURTHER PERTINENT INFO IS RECEIVED, A FOLLOW UP REPORT MAY BE SUBMITTED.
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