MAUDE Adverse Event Report: ALGINATE BASIS; MATERIAL IMPRESSION

Catalog Number 776-2102

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Type  malfunction  

Event Description

It was alleged that a metal piece was found inside basis alginate, cinnamon, 25lb.Bag.

• Brand Name: ALGINATE BASIS
• Type of Device: MATERIAL IMPRESSION
• Manufacturer Contact: suzette rampair-johnson ; 1889 west mission blvd.; pomona, CA 91766 ; 9096713431
• MDR Report Key: 8625157
• MDR Text Key: 145634354
• Report Number: 2016150-2019-00011
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/20/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 776-2102
• Device Lot Number: 6880196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 05/20/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/24/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other