LEAD-CONTAMINATED DENTAL CROWNS MADE IN CHINA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-10 for LEAD-CONTAMINATED DENTAL CROWNS MADE IN CHINA manufactured by .

Event Text Entries

[20928702] It is the dental pt's right to know where their dental crown was made, and exactly what materials the dentist has made a permanent part of the pt's mouth. In light of recent revelations, crowns of foreign origin must be considered to be sources of chronic lead poisoning either with or without a certificate of alloy content. The only certain way to quell the fears is by recalling each pt whose mouth harbors such a crown, and definitively ruling out the possibility of lead contamination. Last week (2008) our local newspaper, reported that on lead-contaminated dental crowns that some dentists have imported from another country. Earlier this month, another country contaminated heparin was reported to have caused the deaths of four us pts. Last summer, the times identified as the source of containing antifreeze that killed pts in another country. The news papers also gave full coverage to the use of by another country toy mfrs. Another country environmental standards are much looser and have not seen lead-contamination as a hazard. Unfortunately, in search of reduced costs, products made under these dangerous loose standards are being imported under the noses of the us regulatory agencies like the (fda, epa). Some dentists have outsourced their dental lab work to another country, using dhl, fedex, or ups to ship round-trip to another country in as little as four or five days. It could be very injurious to your health to have a lead-containing-crown in your mouth. "i guess that tells me i need to be a little bit more concerned about other potential sources of lead," said dr. Who runs central ohio's lead program and poison control center. "i never would have guessed somebody would have put lead into a piece, or a part installed into a human being. " casavant said adults can live with lead poisoning for yrs and not know it. "the symptoms are what we call non-specific - a little ache or a pain - abnormal bowel function," casavant said. Even high blood pressure and kidney trouble could be symptoms, according to casavant. In addition to the physical damage to the body's organ systems, there are a number of subtle neurological symptoms that are also associated with lead poisoning: behavioral symptoms in adults: irritability, unexplained changes in mood or personality, changes in sleep patterns. Inability to concentrate. Memory loss neurological symptoms (caused by effects of lead on the nervous system). Poor coordination. Weakness in hands and feet. Headaches. Seizures. Paralysis. Coma (as listed in webmed), because the symptoms of lead poisoning are painless, until irreparable damage has occurred, it is important that all sources be identified and removed from the patient's environment to prevent further damage. If a lead-contaminated crown is otherwise functioning also without symptoms, its poisoning could continue for years. It would be a signal public health service to have dentists identify, which of their patients have received crowns imported from china. The patients would be empowered to evaluate the potential source of environment pollution concealed inside their body. Early identification is a low-cost preventive-medicine step that could head off disaster before it occurs. It is overdue to issue a recall of crowns that were made overseas to determine, which crowns are leaking poisonous lead contamination. Consumer protections have long mandated recalls of automobile to prevent engine fires, failing brakes, and other defective parts. In the medical field recalls have been issued for cardiac defibrillators and mislabeled medicines. Lead poisoning does not present with the drama of an automobile fire or brake failure. Indeed, it takes a long time for the damage to become noticeable. But we all know, we would want to know "yesterday" if we had a lead-contaminated crown in our mouths, (or a leak in our car's brake system. ) it is time for dentistry's first nationwide recall. In dentistry the regulatory powers are diluted among the several states. The issue of the safety of imported dental devices does not reside in any single agency or authority. The final arbiter of the safety of dental devices is an individual's dentist. There may be solitary disasters occurring in afflicted individuals mouths and brians right now, in slow motion, as you are reading this. I feel that organized dentistry should not pass the buck on this issue merely because we have hyet to codify the needed internal-environment protections in our health-law.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5005906
MDR Report Key1015740
Date Received2008-03-10
Date of Report2008-03-06
Date Added to Maude2008-03-26
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameLEAD-CONTAMINATED DENTAL CROWNS MADE IN CHINA
Generic NameDENTAL CROWNS MADE IN CHINA, IMPORTED INTO US
Product CodeELZ
Date Received2008-03-10
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key985039


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2008-03-10

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