MAUDE Adverse Event Report: SAGE PRODUCTS, LLC Q-CARE; PATIENT PERSONAL HYGIENE KIT

Model Number 6464

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2019

Event Type  malfunction  

Event Description

While using sage kit for mouth care on ventilator, the swab broke off into patients mouth.I reached into his mouth to remove the swab.No harm to patient.

• Brand Name: Q-CARE
• Type of Device: PATIENT PERSONAL HYGIENE KIT
• Manufacturer (Section D): SAGE PRODUCTS, LLC; 3909 3 oaks rd; cary IL 60013
• MDR Report Key: 8771351
• MDR Text Key: 150402491
• Report Number: 8771351
• Device Sequence Number: 1
• Product Code: NSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6464
• Device Catalogue Number: 6464
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/11/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22265 DA