MAUDE Adverse Event Report: MICROAIRE PULSE LAVAGE

Device Problems Leak/Splash (1354); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2015

Event Type  malfunction  

Event Description

This product leaks from the distal tip when it is not activated.It is also difficult to attach the long nozzle to the handpiece.

• Brand Name: PULSE LAVAGE
• Type of Device: PULSE LAVAGE
• Manufacturer (Section D): MICROAIRE
• MDR Report Key: 5277092
• MDR Text Key: 33264822
• Report Number: MW5058396
• Device Sequence Number: 1
• Product Code: FQH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR