AMBU AURASTRAIGHT SIZE 5

Description of Event or Problem

TRAUMATIC REMOVAL OF THE MASK WHEN REMOVED, THE END IN CONTACT WITH THE ROOF OF THE MOUTH CAUSES CUTS AND SOMETIMES SIGNIFICANT BLEEDING. PATIENT OUTCOME: PLEEDING FROM THE PATIENT'S PALATE.

Additional Manufacturer Narrative

THIS COMPLAINT HAS BEEN RE-EVALUATED AS PART OF A CORRECTIVE ACTION RELATED TO AN OBSERVATION ON RISK MANAGEMENT IDENTIFIED DURING AN FDA INSPECTION. H6 - HEATH EFFECT CODE: NO CODE AVAILABLE FOR "CUTTING PATIENT'S THROAT." INVESTIGATION: NEITHER SAMPLE NOR PICTURE IS AVAILABLE FOR INVESTIGATION, THE REPORT FAILURE CANNOT BE VERIFIED. PER THE CUSTOMER REPORTED THAT WHEN REMOVED, THE END IN CONTACT WITH THE ROOF OF THE MOUTH CAUSES CUTS AND SOMETIMES SIGNIFICANT BLEEDING. WE HAVE TRIED TO FIND OUT MORE ABOUT THE FAILED SITUATION WITH THE CUSTOMER. THE CUSTOMER GAVE US FEEDBACK AND SAID THEY'RE UNHAPPY WITH AMBU AND RETURNING ALL THEIR STOCK. AFTER FURTHER COMMUNICATION WITH THE CUSTOMER, THE CUSTOMER FEEDBACK THAT IT'S NOT A MATERIAL VIGILANCE ISSUE, AND BY US, IT CLEARLY SEEMS TO BE A PROBLEM OF MANIPULATION. ACCORDING TO THE IFU, DO NOT USE EXCESSIVE FORCE WHEN INSERTING AND REMOVING AURAGAIN AS THIS CAN LEAD TO TISSUE TRAUMA. THIS IS THE FIRST TIME TO REPORT THE PRODUCT CAUSES CUTS AND SIGNIFICANT BLEEDING FOR THE PATIENT ON DISPOSABLE AURA PRODUCTS IN THE PAST 12 MONTHS. THIS SEEMS THAT IT IS NOT A PRODUCT ISSUE, IT LOOKS LIKE SOMETHING THAT IS SUBJECTIVELY DIFFICULT TO HANDLE OR NOT SATISFIED WITH THE PRODUCTS OFFERED FROM AMBU. THEREFORE, NO FURTHER ACTION IS REQUIRED.