MAUDE Adverse Event Report: ORMCO CORPORATION ALGINATE BASIS; MATERIAL IMPRESSION

Catalog Number 776-2102

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

It was alleged that a piece of metal was found in a 25lb.Bag of alginate.There was no serious injury associated with this incident.

Event Description

Customer found a metal piece in 2 separate 1lb.Bag of alginate upon opening the bag.No injury reported.

Event Description

Customer found a metal piece in 2 separate 1lb.Bags of alginate upon opening the bag.No injury reported.

• Brand Name: ALGINATE BASIS
• Type of Device: MATERIAL IMPRESSION
• Manufacturer (Section D): ORMCO CORPORATION; 1889 w. mission blvd; pomona CA 91766
• Manufacturer (Section G): KERR CORPORATION; 1889 w. mission blvd; pomona CA 91766
• Manufacturer Contact: suzette rampair-johnson ; 1889 w. mission blvd; pomona, CA 91766 ; 9096713431
• MDR Report Key: 8356348
• MDR Text Key: 139829106
• Report Number: 2016150-2019-00006
• 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,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 776-2102
• Device Lot Number: 6880196
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 02/20/2019
• Supplement Dates Manufacturer Received: 02/12/2019
• Supplement Dates FDA Received: 04/26/2019
• Was Device Evaluated by Manufacturer?: No
• 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