FDA Adverse Event
Injury
Summary report: N
KETAC-CEM RADIOPAQUE
MDR report key: 68764
·
Received February 18, 1997
Report
- Report Number
- 9611385-1997-00001
- Event Type
- Injury
- Date Received
- February 18, 1997
- Date of Event
- January 21, 1997
- Report Date
- February 14, 1997
- Manufacturer
- ESPE DENTAL-MEDIZIN GMBH & CO KG
- Product Code
- EMA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
AN 11 YEAR OLD EXPERIENCED A REACTION AFTER ORTHODONTIC BANDS WERE CEMENTED WITH IONOMER CEMENT. REACTION OCCURRED 4 HOURS AFTER THE PROCEUDURE. THE SYMPTOMS WERE SWOLLEN THROAT AND A RASH IN HER ORAL CAVITY. THE PT WAS TAKEN TO AN EMERGENCY ROOM AND TREATED WITH BENADRYL. SYMPTOMS SUBSIDED, HOWEVER, THE SAME SYMPTOMS RETURNED THE SAME DAY AT 4:30 PM. CO WAS INFORMED BY DR THAT THE PT WAS TAKEN BACK TO THE EMERGENCY ROOM AND WAS TREATED WITH PREDNISONE TO COUNTERACT THE INFLAMMATION IN HER THROAT. THE DR IS REFERRING THE PT TO AN ALLERGIST TO BE TESTED ON ALL THE PRODUCTS HE USED. HE REQUESTED THE INGREDIENTS IN PRODUCT FOR THESE TESTS TO BE PERFORMED. CO FAXED THE INFO HE REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KETAC-CEM RADIOPAQUE | GLASS IONOMER CEMENT | EMA | ESPE DENTAL-MEDIZIN GMBH & CO KG | NA | 378-042 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Hospitalization| R | ORTHODONTIC BANDS| LATEX GLOVES |