MAUDE Adverse Event Report: JAEGER MEDICAL GMBH MICORGARD II FILTER; BREATHING MOUTHPIECE, SINGLE-USE

Model Number	MICORGARD II FILTER
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.

• Brand Name: MICORGARD II FILTER
• Common Device Name: BREATHING MOUTHPIECE, SINGLE-USE
• Manufacturer (Section D): JAEGER MEDICAL GMBH; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• Manufacturer Contact: jared cardon ; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• MDR Report Key: 22326296
• Report Number: 9615102-2025-00173
• Device Sequence Number: 8812067
• Product Code: BYP
• UDI-Device Identifier: 04250892907383
• UDI-Public: (01)04250892907383
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MICORGARD II FILTER
• Device Catalogue Number: V-892893
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown