MAUDE Adverse Event Report: GC CORP, FUJI OYAMA FACTORY GC FUJICEM 2 AUTOMIX; NONE

Catalog Number 004599

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Respiratory Distress (2045)

Event Date 10/10/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, dr (b)(6) had a pt that he placed a unit 3 pfm bridge using gc fujicem 2.Pt complained of some breathing problems to the dental staff.Dentist followed up by phone the next day and was told she was doing better but by friday morning, (b)(6), she had developed severe breathing problems and was hospitalized.

Manufacturer Narrative

Dentist was concerned that possibly the silicone dioxide in the product cement may be the cause, dr (b)(4) from gc america spoke with dr (b)(6).An open formula and sds was sent to dr (b)(6) for him to forward to pt's physician.Dr (b)(4) reviewed proprietary formula and noted no sulfites are in the product.Product does contain sodium benzensulfinate dihydride, which is a preservative,.

• Brand Name: GC FUJICEM 2 AUTOMIX
• Type of Device: NONE
• Manufacturer (Section D): GC CORP, FUJI OYAMA FACTORY; 584-1 nakahinata, oyama-cho; sunto-gun, shizuoka-ken 410- 1307; JA 410-1307
• Manufacturer Contact: 3737 west 127th st.; alsip, IL 60803 ; 7089263090
• MDR Report Key: 4251829
• MDR Text Key: 5012144
• Report Number: 1410097-2014-00004
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2016
• Device Catalogue Number: 004599
• Device Lot Number: 1401131
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/10/2014
• Event Location: Other
• Date Manufacturer Received: 10/10/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization