FDA.reportPublic FDA data

MAUDE MDR 699090

MDR report key
699090
Report number
1017522-2006-00002
Event key
0
Event type
3
Date of event
2006-01-10
Date received
2006-04-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
11727 FRUEHAUF DR CHARLOTTE NC 28273 US
Phone
704-704-7045
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COACHMAN II DENTAL CHAIRDENTAL CHAIRPELTON & CRANENRUL63006801NANRY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-04-0701. H; 2. L; 3. R

Event Narratives#

D

Patient 1

A MOTHER AND HER THREE CHILDREN WERE ALL IN A DENTAL OPERATORY AT THE SAME TIME WHILE THE OLDEST CHILD, WAS HAVING HIS TEETH CLEANED. WHEN THE DENTAL HYGIENIST WAS FINISHED CLEANING THE CHILD'S TEETH SHE HIT THE EXIT BUTTON TO POSITION THE CHAIR TO LET THE CHILD OUT, HOWEVER, SHE DID NOT REALIZE THAT THE YOUNGEST CHILD HAD CRAWLED UP UNDER THE CHAIR. THE CHAIR WENT DOWN ONTO THE CHILD'S HEAD AND FACE. THE CHILD STARTED TO SCREAM SO THE DENTAL HYGIENIST STOPPED THE CHAIR AND RAISED IT BACK UP. THE MOTHER GRABBED THE CHILD BY THE FEET AND PULLED THE CHILD OUT. THE CHILD RECEIVED SEVERE LACERATIONS TO THE FACIAL AREA AND SOME BLEEDING TO THE BACK OF HIS HEAD. THE CHILD WAS SENT IMMEDIATELY TO A HOSPITAL.