MAUDE Adverse Event Report: DENTSPLY IRM; CEMENT DENTAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hair Loss (1877); No Code Available (3191)

Event Date 03/30/2015

Event Type  Injury  

Event Description

I had dental fillings that had bpa derivatives and they caused my hair loss after each successive implant of filling.So with each filling carries more hair loss that the last.I notice strange chemical taste from these fillings leeching into my saliva.Recently, i had these bpa fillings replaced with zinc oxide eugenol polymethacrylate fillings and they too had this weird chemical taste.I noticed more hair loss this time around even though my hair loss plateaued or stabilized when i had the bpa fillings for over a year.

• Brand Name: IRM
• Type of Device: CEMENT DENTAL
• Manufacturer (Section D): DENTSPLY
• MDR Report Key: 4664734
• MDR Text Key: 5602962
• Report Number: MW5041891
• Device Sequence Number: 1
• Product Code: EMA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/30/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 82