MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL COMFORT PLUS¿ PREMIUM SALIVA EJECTORS

Model Number	ZWWCP
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Rash (2033)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned to manufacturer.Device lot number not provided to manufacturer.Review of complaint records for the last five years found no complaints of allergic reactions for suspected device.Adverse event cause could not be established due to lack of information and device not returned to manufacturer.
Event or Problem Description
Distributor reported that a patient had a reaction to a saliva ejector.The patient's face broke out.

• Brand Name: COMFORT PLUS¿ PREMIUM SALIVA EJECTORS
• Common Device Name: SALIVA EJECTOR
• Manufacturer (Section D): CROSSTEX INTERNATIONAL; 6789 west henrietta rd.; rush NY 14543
• Manufacturer (Section G): CROSSTEX INTERNATIONAL; 6789 west henrietta rd.; rush NY 14543
• Manufacturer Contact: stephanie wasielewski ; 6789 west henrietta rd.; rush, NY 14543 ; 8472574500
• MDR Report Key: 22201637
• Report Number: 1319130-2025-00006
• Device Sequence Number: 15364581
• Product Code: DYN
• UDI-Device Identifier: 10732224000678
• UDI-Public: (01)10732224000678
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ZWWCP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 06/13/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female