MAUDE Adverse Event Report: IVOCLAR VIVADENT IPS E. MAX PRESS CROWN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Swelling (2091); Reaction (2414)

Event Date 07/09/2017

Event Type  Injury  

Event Description

Adverse reaction to product.I had an allergic reaction to an ips e.Max press crown and needed to take prednisone in order for the swelling to go down.I had the ips e.Max press crown removed and the problems were resolved.I want to make sure that others aware of these crowns and that there can be adverse reactions from them.Is the product compounded: yes.Date the person first started taking or using the product: (b)(6) 2016.Date the person stopped taking or using the product: (b)(6) 2017.Did the problem stop after the person reduced the dose or stopped taking or using the product: yes.Why was the person using the product: it was a crown on tooth number 13.

• Brand Name: IPS E. MAX PRESS CROWN
• Type of Device: IPS E. MAX PRESS CROWN
• Manufacturer (Section D): IVOCLAR VIVADENT
• MDR Report Key: 6900133
• MDR Text Key: 87800116
• Report Number: MW5072513
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2017

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 99