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