FDA Adverse Event
Injury
Summary report: N
MULTI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT
MDR report key: 93131
·
Received May 22, 1997
Report
- Report Number
- 2020467-1997-00006
- Event Type
- Injury
- Date Received
- May 22, 1997
- Report Date
- May 2, 1997
- Manufacturer
- 3M UNITEK
- Product Code
- DYH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
DENTAL ASSISTANT HAD ALLERGIC RESPONSE ON HER HANDS TO MULTICURE GLASS LONOMER BAND CEMENT. DENTAL ASSISTANT'S PHYSICIAN PRESCRIBED A TOPICAL OINTMENT/CREAM FOR TREATMENT AND ADVISED DENTAL ASSISTANT TO DISCONTINUE WORKING WITH THE GLASS IONOMER BAND CEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT | ORTHODONTIC CEMENT/ADHESIVE | DYH | 3M UNITEK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other | NOT APPLICABLE. |