V4 4FB QUIKTRAK 9100001 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2005-03-04 for V4 4FB QUIKTRAK 9100001 NA manufactured by Bhm Medical, Inc..

Event Text Entries

[21628041] Two parts of the track system suddenly separated and the ceiling lift fell on the floor. The spreader bar hit the resident on the forehead and caused a small bruise on forehead.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9681684-2005-00001
MDR Report Key580983
Report Source01,06
Date Received2005-03-04
Date of Report2005-02-14
Date of Event2005-01-30
Date Mfgr Received2005-02-01
Device Manufacturer Date2003-01-01
Date Added to Maude2005-03-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactTRACI GIOVENCO
Manufacturer Street50 N. GARY AVE STE A
Manufacturer CityROSELLE IL 50172
Manufacturer CountryUS
Manufacturer Postal50172
Manufacturer Phone6303076140
Manufacturer G1BHM MEDICAL INC.
Manufacturer Street*
Manufacturer CityMAGOG, QC
Manufacturer CountryCA
Single Use3
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameV4 4FB QUIKTRAK
Generic NameCEILING LIFT
Product CodeKNG
Date Received2005-03-04
Model Number9100001
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key570823
ManufacturerBHM MEDICAL, INC.
Manufacturer Address2001 TANGUAY ST. MAGOG, QUEBEC CA
Baseline Brand NameV4 4FB QUIKTRAK
Baseline Generic NameCEILING LIFT
Baseline Model No9100001
Baseline Catalog NoNA
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2005-03-04

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