FDA.reportPublic FDA data

MAUDE MDR 31182

MDR report key
31182
Report number
MW1008605
Event key
0
Event type
3
Date of event
1995-11-16
Date received
1996-03-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COACHMAN II DENTAL CHAIRPATIENT DENTAL CHAIRPELTON/CRANE CO.KLCCH2NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11996-03-1301. H

Event Narratives#

D

Patient 1

ON 11/16/95 WHEN RPTR'S HYGIENIST WAS SEATING HER PT THE CHAIR CAME DOWN ON HER FOOT. SHE WAS TRAPPED IN THIS POSITION, DUE TO NO OVERRIDE, FOR 18 MINUTES, RESULTING IN A BROKEN FOOT. RPTR CONTACTED 911 TO HAVE EMS UNIT HELP EXTRICATE THE FOOT. HER HYGIENIST MISSED WORK FOR ALMOST 3 MONTHS BECAUSE OF THIS EVENT. IT IS RPTR'S CONTENTION THAT THE CHAIR IS UNSAFE BECAUSE THE BASE COMES TOO CLOSE TO THE FLOOR. THERE IS A FOOT CONTROL PEDAL THAT, IF IT ENDS UP DIRECTLY BENEATH THE BASE, CAN TRAP THE FOOT. ONCE TRAPPED IN "DOWN" POSITION THERE IS NO MECHANISM BY WHICH TO BYPASS THIS. ON MONDAY, 11/27/95, A MFR'S REP CAME TO RPTR'S OFFICE TO TEST THE CHAIR. HE AGREED THAT THERE WAS A PROBLEM WITH THE CHAIR AND IT WAS A MATTER THAT NEEDED TO BE EXAMINED FURTHER. HE WAS TOLD THE MFR WOULD CONTACT HIM. THEY NEVER DID.