UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-29 for UNK manufactured by Unk.

Event Text Entries

[290948] Pt was poisioned by a dentist who used a malfunctioning amalgam manufacturing machine. The fillings subsequently fell out which is why pt got a blood test. It was 80% of the highest limit before intervention would be mandatory. His machine sounded like an old car or washing machine that was on its last legs and long overdue for the dump. The fillings -which pt mostly saved- fell out over a 2 year or so period. The base line -normal- mercury amount was never determined but was likely 1 or less before this happened. Pt doesn't have their papers with them now. Reply and pt will definitely get the exact dates when they can. Pt is having to sue this person and have not started recovery yet so the above date is probably wrong. Mercury and silver is both toxic and the damage has already been done... Pt needs help to confiscate the malfunctioning machine if indeed he still is using it. Pt turned him in to the attorney general for toxic -tort- enviroment but they did nothing. Who is supposed to inspect and maintain those machines anyways? The dental board won't answer any questions about that or the way he treated pt. Talk about denial... Geez. Can't anyone get any justice any more? The yes in # 9 above is conditional. He may have destroyed, replaced or remanufactured it by now. Pt wonders how many hundreds of people he poisioned with that piece of junk.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1029167
MDR Report Key475528
Date Received2003-07-29
Date of Report2003-07-29
Date of Event1999-06-22
Date Added to Maude2003-08-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameUNK
Generic NameAMALGAM MANUFACTURING MACHINE
Product CodeEFD
Date Received2003-07-29
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID NumberUNK
Device Expiration Date1999-06-22
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagY
Date Removed*
Device Sequence No1
Device Event Key464370
ManufacturerUNK
Manufacturer AddressUNK UNK *


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit 2003-07-29

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