FDA.reportPublic FDA data

MAUDE MDR 379294

MDR report key
379294
Report number
1416605-2002-00001
Event key
0
Event type
3
Date of event
2000-10-09
Date received
2002-02-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
KEITH DUNN, DIRECTOR
Address
3232 NORTH ROCKWELL ST. CHICAGO IL 60618 US
Phone
773-773-7739
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HU-FRIEDYELEVATORHU-FRIEDY MANUFACTURINGEMNE301E301*NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12002-02-2701. H; 2. L; 3. R

Event Narratives#

D

Patient 1

DURING THE COURSE OF ATTEMPTING TO EXTRACT TOOTH #16 ON THE PATIENT, THE DENTIST BROKE OFF THE CAP OF PATIENTS WISDOM TOOTH LACERATING THE TOUNGUE AND PIERCING THE FLOOR OF THE PATIENTS MOUTH APPROXIMATELY 3MM WITH A SHARP DENTAL INSTRUMENT WHICH HAS BEEN IDENTIFIED TO BE AN E301 ELEVATOR. THE PATIENT BEGAN TO BLEED PROFUSELY AND A SUBLINQUAL HEMATOMA FORMED WHICH OBSTRUCTED THE PATIENT'S AIRWAY. THE PATIENT WAS HOSPITALIZED WHERE AN EMERGENCY TRACHEOSTOMY WAS PERFORMED.