MAUDE Adverse Event Report: GC FUJI OYAMA FACTORY FUJI PLUS CAPSULE

Catalog Number 425030

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 10/27/2014

Event Type  Injury  

Event Description

Pt experienced allergic reaction after receiving fuji plus from her dentist during a dental procedure.Within 24 hrs pt had a reaction and went to hosp because of swelling of her tongue and chin.Pt was hospitalized and received steroid treatment.

• Brand Name: FUJI PLUS CAPSULE
• Type of Device: UNK
• Manufacturer (Section D): GC FUJI OYAMA FACTORY; 584-1 nakahinata, oyama-cho; sunto-gun, shizuoka-ken 410- 1307; JA 410-1307
• Manufacturer (Section G): GC AMERICA, INC.; 3737 west 127th st.; alsip IL 60803
• Manufacturer Contact: 3737 west 127th st.; alsip, IL 60803
• MDR Report Key: 4337068
• MDR Text Key: 5141423
• Report Number: 1410097-2014-00005
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 11/20/2014,12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 425030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2014
• Distributor Facility Aware Date: 11/18/2014
• Event Location: Other
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization