AMBU AURASTRAIGHT U SIZE 4
Received Jun 24, 2026
Report 9610691-2026-00021 · MDR key 25603752
Device
Product problems
- Improper or Incorrect Procedure or Method
Patient
NA · Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
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 FOR INVESTIGATION, VISUAL INSPECTION IS NOT PERFORMED, THE CUSTOMER REPORTED FAILURE CANNOT BE VERIFIED. PER THE CUSTOMER REPORTED THAT THE PRODUCT CUTTING PATIENT'S THROATS, IT MAY BE CAUSED BY THE EXCESSIVE FORCE DURING INSERTION OR MAY BE CAUSED BY SHARP EDGES ON THE PRODUCT. DUE TO LIMITED INFORMATION, THE ROOT CAUSE CANNOT BE DEFINED. THE PATIENT WAS INVOLVED, BUT THE PATIENT CONDITION IS UNKNOWN, THE COMPLAINT RATE IS LOW. DUE TO THE ROOT CAUSE THAT CANNOT BE DEFINED AS LIMITED INFORMATION, THE CORRECT ACTION WILL NOT BE TAKEN AT THIS TIME. SINCE THE ROOT CAUSE CANNOT BE IDENTIFIED, THERE IS NO ADDITIONAL ACTION IS NOT REQUIRED AT THIS MOMENT.
Description of Event or Problem
WE HAVE BEEN RECEIVING A LOT OF PROVIDER COMPLAINTS ABOUT THE LMA'S CUTTING PATIENT'S THROATS. SPECIFICALLY THE 3244.