IVAC PROBE COVERS

Description of Event or Problem

A DRAFT CASE PRESENTATION SUBMITTED TO MANUFACTURER BY AUTHOR SPECULATING ASSOCIATION BETWEEN TURBO TEMP PROBE COVER TO A CASE OF NECROTIZING FASCIITIS THAT RESULTED IN DEATH OF PATIENT. THE REPORTER MAINTAINS IT IS PLAUSABLE THAT A PROBE COVER MAY HAVE CAUSED A MINOR RECTAL MUCOSAL INJURY SUFFICIENT TO INITIATE PERIANAL NECROTIZING FASCIITIS. THE CONDITION RESULTED IN PATIENT DEATH. AUTOPSY DID NOT DISCLOSE A SPECIFIC ETIOLOGY OR CAUSE OF THE PERIANAL NECROTIZING FASCIITIS. CUSTOMER CONTACTED. CUSTOMER FAMILIAR WITH THE CASE PRESENTATION AND PHOTOGRAPHS, STATED THE PHOTOGRAPHS PROVIDED IN THE CASE PRESENTATION WERE NOT INVOLVED IN INCIDENT NOR ARE THEY FROM THE SAME BOX OF COVERS INVOLVED IN THE INCIDENT. CUSTOMER HAD NO FURTHER INFORMATION OR PRODUCTS INVOLVED IN EVENT FOR INVESTIGATION.

Additional Manufacturer Narrative

MANUFACTURER'S REPORT DATE: 10/23/06. PATIENT INFORMATION REQUESTED AND ALL AVAILABLE INFORMATION IS INCLUDED. THIS REPORT WAS FILED BY THE MANUFACTURER.