MICORGARD II FILTER
Received Jun 25, 2025 · Event occurred Jun 2, 2025
Report 9615102-2025-00173 · MDR key 22326296
Device
Generic name
Breathing Mouthpiece, Single-use
Manufacturer
Jaeger Medical GmbhModel number
MICORGARD II FILTERCatalog number
V-892893
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
NA · Unknown
- Hypersensitivity/Allergic reaction
- Hypersensitivity/Allergic reaction
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A CUSTOMER HAS CONCERNS ABOUT AN ALLERGIC REACTION OF A PATIENT IN ASSOCIATION WITH THE BLUE TIP OF THE MICROGARD FILTER. DESPITE REMINDERS, THE CUSTOMER DID NOT PROVIDED FURTHER INFORMATION.
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RETURNED, AND NO ADDITIONAL INFORMATION REGARDING THE PRODUCT OR THE INCIDENT HAS BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE FURTHER DETAILS ARE AVAILABLE AND AN INVESTIGATION INTO THE INCIDENT CAN BE CONDUCTED. THE RISK OF AN ALLERGIC REACTION IS ADDRESSED WITHIN THE RISK MANAGEMENT DOCUMENTATION AND HAS BEEN ASSESSED AS AN ACCEPTABLE HEALTH RISK.