CHAIRMAN DENTAL CHAIR L1 007890

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1998-03-11 for CHAIRMAN DENTAL CHAIR L1 007890 manufactured by Pelton & Crane, Llc.

Event Text Entries

[21247055] It was reported by a dr's office that a dental hygienist was performing routine hygiene on a pt in a chairman dental chair when the chair's lift linkage broke causing the seat assembly along with the pt to fall down to the floor. There were no serious injuries reported. The pt received a scratch on her face. The hygienist received a small laceration on her hand. No medical treatment was required for either pt or hygienist.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1017522-1998-00005
MDR Report Key155824
Report Source08
Date Received1998-03-11
Date of Report1998-03-11
Date Mfgr Received1998-02-16
Device Manufacturer Date1974-08-01
Date Added to Maude1998-03-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Remedial ActionRP
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameCHAIRMAN DENTAL CHAIR
Generic NameDENTAL OPERATORY CHAIR
Product CodeKLC
Date Received1998-03-11
Model NumberL1
Catalog Number007890
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key151785
ManufacturerPELTON & CRANE, LLC
Manufacturer AddressPO BOX 7800 CHARLOTTE NC 282417800 US
Baseline Brand NameCHAIRMAN
Baseline Generic NameDENTAL CHAIR
Baseline Model NoL1
Baseline Catalog No007890
Baseline IDNA
Baseline Device FamilyDENTAL OPERATORY WITH ACCESSORIES
Baseline Shelf Life ContainedA
Baseline Shelf Life [Months]*
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 1998-03-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.