IPS EMPRESS CAD 602568

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-01 for IPS EMPRESS CAD 602568 manufactured by Ivoclar Vivadent Ag.

Event Text Entries

[48715858] Ingestion of foreign objects can occur at any time during dental procedures. Once a foreign object has reached the stomach it is expected that it will pass through the gastrointestinal tract as a result of peristalsis movement without complication, usually after a 7-10 day period. Follow up with patient on (b)(6) 2016 indicated improvement and pill camera procedure revealed evidence of healing. Patient reports ct scans, colonoscopy and endoscopy procedures conducted with no evidence of broken tooth piece found.
Patient Sequence No: 1, Text Type: N, H10


[48715859] Patient swallowed portion of ips empress cad crown that had been placed on tooth #18 by the dentist on (b)(6) 2013. Patient returned to dentist on (b)(6) 2016 indicating that a piece of the crown was swallowed after eating almonds. The doctor confirmed that a portion of the patients crown fractured on the distolingual cusp. On (b)(6) 2016 the patient returned to the office claiming the portion of the crown swallowed caused pain and damage to his digestive system.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612352-2016-00002
MDR Report Key5765807
Date Received2016-07-01
Date of Report2016-07-01
Date of Event2016-06-01
Date Mfgr Received2016-06-02
Date Added to Maude2016-07-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. DONNA HARTNETT
Manufacturer Street175 PINEVIEW DR.
Manufacturer CityAMHERST NY 14228
Manufacturer CountryUS
Manufacturer Postal14228
Manufacturer Phone7166912260
Manufacturer G1IVOCLAR VIVADENT AG
Manufacturer StreetBENDERERSTRASSE 2
Manufacturer CitySCHAAN, 9494
Manufacturer CountryLS
Manufacturer Postal Code9494
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameIPS EMPRESS CAD
Generic NamePORCELAIN/POWDER
Product CodeEIH
Date Received2016-07-01
Catalog Number602568
OperatorDENTIST
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerIVOCLAR VIVADENT AG
Manufacturer AddressBENDERERSTRASSE 2 SCHAAN, 9494 LS 9494


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2016-07-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.