MAUDE Adverse Event Report: IVOCLAR VIVADENT AG TELIO CS DESENSITIZER; DENTAL MATERIAL, DESENSITIZING RESIN

Catalog Number 627911AN

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Numbness (2415)

Event Date 08/17/2014

Event Type  malfunction  

Event Description

According to the report from the dentist the pt complained of unpleasant numbness directly after the prophylaxis treatment.After two days the pt contacted the dentists again and requested an appointment because the gingiva was discolored.

Manufacturer Narrative

Telio cs desensitizer is used to close dentine tubuli and for example to treat sensitive tooth necks.In this particular case the pt was aware of numbness during the treatment.The symptoms were described by the pt.They could indicate an allergic reaction.Production records for this batch were normal.

• Brand Name: TELIO CS DESENSITIZER
• Type of Device: DENTAL MATERIAL, DESENSITIZING RESIN
• Manufacturer (Section D): IVOCLAR VIVADENT AG; bendererstrasse 2; schaan FL-9 494; LS FL-9494
• Manufacturer (Section G): IVOCLAR VIVADENT AG; bendererstrasse 2; schaan FL-9 494; LS FL-9494
• Manufacturer Contact: sandra cakebread ; bendererstrasse 2; schaan FL-94-94 ; LS FL-9494 ; 2353535
• MDR Report Key: 4237297
• MDR Text Key: 21879187
• Report Number: 9612352-2014-00002
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• PMA/PMN Number: K003407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Dentist
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 08/16/2016
• Device Catalogue Number: 627911AN
• Device Lot Number: T10346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/15/2014
• Event Location: Other
• Date Manufacturer Received: 08/15/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention