FDA Adverse Event
Summary report: N
AMES CROWN AND BRIDGE INLAY CEMENT
MDR report key: 10505
·
Received August 27, 1993
Report
- Report Number
- MW4000007
- Date Received
- August 27, 1993
- Manufacturer
- TELEDYNE GETZ
- Product Code
- EMA
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
A 10-YR-OLD BOY WAS ILL FROM 5/93 UNTIL 8/3/93. HE WOULD EXPERIENCE NAUSEA, VOMITING IN THE AM, AND THEN FEEL BETTER ABOUT ONE HR OR SO LATER. ALL KINDS OF TESTS WERE CONDUCTED, BUT ALL WERE NEGATIVE. HE WAS IN THE ER TWICE. THE DRS GOT TOGETHER T0 TRY TO FIND OUT WHAT MIGHT BE CAUSING THE PROBLEM. THE ONLY THING DIFFERENT WAS THAT HE HAD STARTED WEARING BRACES. HE HAD TO USE AN EXPANDER WHICH WAS HELD IN PLACE BY AN INLAY CEMENT. THEY DECIDED TO REMOVE THE BRACES AND ABOUT A WK AGO HE WAS 100% BETTER. THEY DECIDED HE WAS SUFFERING FROM A REACTION TO THE CEMENT. HE ALSO HAD A METALLIC TASTE WHILE WEARING THE BRACES. THE BRACES WERE MADE OF STAINLESS STEEL, HYPOALLERGENIC TYPE DEVICE. THE INLAY CEMENT WAS A SLOW RELEASE ZINC PHOSPHATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMES CROWN AND BRIDGE INLAY CEMENT | EMA | TELEDYNE GETZ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |