FDA Adverse Event
Malfunction
Summary report: N
IVORY RUBBER DAM CLAMP
MDR report key: 37789
·
Received September 12, 1996
Report
- Report Number
- MW1009919
- Event Type
- Malfunction
- Date Received
- September 12, 1996
- Manufacturer
- DENTAL PRODUCTS DIV. MILES, INC.
- Product Code
- EEF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MN, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
RUBBER DAM CLAMP WAS PLACED AND BROKE IN THE PT'S MOUTH. IT COULD HAVE BEEN SWALLOWED CAUSING ASPIRATION OF THE CLAMP, BUT LUCKILY IT WAS NOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IVORY RUBBER DAM CLAMP | RUBBER DAM CLAMP | EEF | DENTAL PRODUCTS DIV. MILES, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |