DENTURES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-04 for DENTURES manufactured by .

Event Text Entries

[72090022] At the beginning of (b)(6) i contacted dr. (b)(6) to make a new denture to replace my 12 year old dentures. They took x-rays and scheduled the next visit. This appointment was with the dental technician, the dentist's husband (b)(6). (b)(6) arranged for a case to me made. I worked with (b)(6) until (b)(6). He told me his wife has fibromyalgia. There were times i waited for 1. 5 hours before i saw (b)(6). When the dentures were completed i told (b)(6) they did not feel right. (b)(6) blamed the lab. We go through the process again. After wearing for 2 days a tooth fell out of the socket and the dentures hurt my mouth. I go back to see (b)(6). His attitude has changed. He said i knew his wife was sick. He talks about fighting. One week later i see dr. (b)(6). She is grinding the dentures to make them minimum size. When i tell her the teeth do not fit, she suggests i sleep with them, the mouth will adjust. She appears angry and nervous. The other personnel are surrounding me in an intimidating way. They tell me they are recording me. I remain calm and chose my words carefully. I ask for a paper saying the dentures are unacceptable. They say no. They call the police. There is now a restraining order against me. Disability paid (b)(6) and i paid (b)(6). I have dentures that are not usable. I am wearing my old 12 year old dentures. What can be done about the incompetence and dishonesty of this dental practice? They do not belong to the dental association. (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5068907
MDR Report Key6459942
Date Received2017-04-04
Date of Report2017-04-03
Date of Event2016-12-21
Date Added to Maude2017-04-05
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameDENTURES
Generic NameDENTURES
Product CodeNSL
Date Received2017-04-04
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-04-04

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