MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-08-28 for DENTAL CROWN manufactured by David Mauk.
[17795]
Complainant is a dentist. Husband, who is an athlete & in healthy condition, received 9 dental crowns from dr over a 6 month period between 7/93 & 9/93. He immediately started experiencing symptoms such as paralysis, dizzyness, nausea, & fatigue, & 5 months after the first crown was received "he could not function". He was diagnosed as having brain damage as well. During a visit to dr on 1/13/94 he had a seizure & was treated at the hosp. All the crowns were removed 3/95. Lab analysis of the crown material showed the crowns to contain 33 elements including arsenic & mercury. Complainant talked to several crown mfrs in the area & was told that this mfr is known as "the scrap metal man". Dentist apparently sends all his orders to this mfr, & the mfr only supplies the dentist's practice. Complainant has names, phone numbers, & addresses of other pts of dr who have experienced similar symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000762 |
| MDR Report Key | 26710 |
| Date Received | 1995-08-28 |
| Date of Report | 1995-07-31 |
| Date of Event | 1993-07-01 |
| Date Added to Maude | 1995-10-11 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DENTAL CROWN |
| Generic Name | CROWN |
| Product Code | ELZ |
| Date Received | 1995-08-28 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 27487 |
| Manufacturer | DAVID MAUK |
| Manufacturer Address | 1968 ARABIAN GARDENRVILLE NV 89410 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1995-08-28 |