MAUDE Adverse Event Report: UNKNOWN PALAMIX; DISPENSER, CEMENT

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 11/08/2021

Event Type  malfunction  

Event Description

(palamix) the first package that was open couldn't push the pump to mix.Another pump was opened and it would not retract when mixing resulting in the powder not being properly mixed.This resulted in a third palamix to be opened.Action: removed from theatre as unable to use outcome: awaiting outcome of product complaint (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PALAMIX
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17533862
• MDR Text Key: 321428397
• Report Number: MW5140765
• Device Sequence Number: 1
• Product Code: KIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2021

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1