CURAPLEX

Description of Event or Problem

IT WAS REPORTED, THE ITEM WAS RECEIVED WITH A DEFLATED MASK, (BAG VALVE MASK (BVM)), WHICH CAUSED A SERIOUS (UNSPECIFIED) ISSUE WHEN THEY ATTEMPTED TO USE IT DURING A CARDIAC ARREST "[EVENT]". NO ADDITIONAL INFORMATION PROVIDED CONCERNING THE REPORTED EVENT, INCLUDING PATIENT OUTCOME; ADDITIONALLY, THERE WAS NO REPORT OF HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATIONA REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS.ALL INFORMATION REASONABLY KNOWN AS OF 21 JUL 2026 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC.SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS (b)(4).THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.