MAUDE Adverse Event Report: HENRY SCHEIN, INC. ACCLEAN PROPHYLAXIS PASTE; AGENT, POLISHING ABRASIVE, ORAL CAVITY

Lot Number 0730191

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)

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

Event Type  malfunction  

Event Description

The single unit dose cups had holes or perforations in the tops of all the units in the box, thus making them open and nonsterile.

• Brand Name: ACCLEAN PROPHYLAXIS PASTE
• Type of Device: AGENT, POLISHING ABRASIVE, ORAL CAVITY
• Manufacturer (Section D): HENRY SCHEIN, INC.
• MDR Report Key: 9328482
• MDR Text Key: 166790880
• Report Number: MW5091102
• Device Sequence Number: 1
• Product Code: EJR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 11/03/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 0730191
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1