FDA.reportPublic FDA data

MAUDE MDR 53012

MDR report key
53012
Report number
1017522-1996-00031
Event key
0
Event type
3
Date of event
1996-10-11
Date received
1996-11-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CHAIRMANDENTAL OPERATORY CHAIRSIEMENS PELTON & CRANEKLCL107890UNKNRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11996-11-210

Event Narratives#

D

Patient 1

IT WAS REPORTGED BY THE DENTIST THAT AS HE WAS RAISING THE CHAIRBACK UP TO THE EXIT POSITION THAT HE HEARD A CRACKING SOUND. UPON FURTHER INVESTIGATION HE FOUND THAT THE CHAIR BACK HAD CRACKED AT THE LIFT OR PUSHER MECHANISM AT THE BASE OF THE CHAIR BACK. THIS EVENT DID NOT OCCUR DURING THE DENTAL PROCEDURE BUT DURING THE EXITING OR RAISING OF THE PT BACK TO THE UPRIGHT POSITION. THE OFFICE DID NOT REPORT ANY INJURY AS A RESULT OF THIS INCIDENT.