RECLINING DENTAL CHAIR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-12 for RECLINING DENTAL CHAIR manufactured by .

Event Text Entries

[17220927] Spinal dislocation caused by excessive protruding non-adjustable padding of fully reclined dental chair for the entire duration of teeth-cleaning appointment. In reclined position, the huge lumbar "support" distorted my spine and caused joints to dislocate. Pain from dislocated back joints increased during the appointment and persisted afterwards. One day later, use of an inclined sit-up board enabled the back joints to shift back into proper position; this resolved the dislocation and pain caused by the fixed huge lumbar hump on the reclined dental chair.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5039678
MDR Report Key4352651
Date Received2014-12-12
Date of Report2014-12-12
Date of Event2013-01-14
Date Added to Maude2014-12-23
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameRECLINING DENTAL CHAIR
Generic NameRECLINING DENTAL CHAIR
Product CodeKLC
Date Received2014-12-12
OperatorHEALTH PROFESSIONAL
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2014-12-12

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