PORCELAIN CROWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-28 for PORCELAIN CROWN manufactured by .

Event Text Entries

[4314377] Pt called to report severe adverse reactions to 4 porcelain crowns implanted in his mouth in (b)(6) 2009. Pt stated he experiences infections, constant pain migraines, chronic neck and shoulder pain. He says the bacteria from the infected crowns is going into his body and making him very sick, and causes him problems with sleep and constant pain. Pt stated he has reached out to his local government and social workers to help him, but has received no help.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5034779
• MDR Report Key: 3660706
• Date Received: 2014-02-28
• Date of Report: 2014-02-28
• Date of Event: 2009-10-01
• Date Added to Maude: 2014-03-06
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: PORCELAIN CROWN
• Generic Name: PORCELAIN CROWN
• Product Code: NSO
• Date Received: 2014-02-28
• Device Sequence No: 1
• Device Event Key: 0

Device Sequence Number: 2

• Brand Name: PORCELAIN CROWN
• Generic Name: PORCELAIN CROWN
• Product Code: NSO
• Date Received: 2014-02-28
• Device Sequence No: 2
• Device Event Key: 0

Device Sequence Number: 3

• Brand Name: PORCELAIN CROWN
• Generic Name: PORCELAIN CROWN
• Product Code: NSO
• Date Received: 2014-02-28
• Device Sequence No: 3
• Device Event Key: 0

Device Sequence Number: 4

• Brand Name: PORCELAIN CROWN
• Generic Name: PORCELAIN CROWN
• Product Code: NSO
• Date Received: 2014-02-28
• Device Sequence No: 4
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-02-28