ERGOSTYLE ERGOSTYLE ELEVATION 8760

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 2002-06-03 for ERGOSTYLE ERGOSTYLE ELEVATION 8760 manufactured by Chattanooga Group A Division Of Encore Medical L.p..

Event Text Entries

[231210] Lifting motor over extended causing the treatment table to fall. No consequences to patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1022819-2002-00001
MDR Report Key397748
Report Source08
Date Received2002-06-03
Date of Report2002-06-03
Date Mfgr Received1999-08-26
Device Manufacturer Date1997-10-01
Date Added to Maude2002-06-06
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
Manufacturer ContactMICHAEL TREAS
Manufacturer Street4717 ADAMS RD
Manufacturer CityHIXSON TN 37343
Manufacturer CountryUS
Manufacturer Postal37343
Manufacturer Phone4238707218
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction Number1180
Event Type3
Type of Report3

Device Details

Brand NameERGOSTYLE
Generic NameCHIROPRACTIC TREATMENT TABLE
Product CodeJFB
Date Received2002-06-03
Model NumberERGOSTYLE ELEVATION
Catalog Number8760
Lot Number*
ID NumberCORRECTIVE ACTION #1180
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key386795
ManufacturerCHATTANOOGA GROUP A DIVISION OF ENCORE MEDICAL L.P.
Manufacturer Address4717 ADAMS RD. HIXSON TN 37343 US
Baseline Brand NameERGOSTYLE
Baseline Generic NameCHIROPRACTIC TREATMENT TABLE
Baseline Model NoERGOSTYLE ELEVA
Baseline Catalog No8760
Baseline IDCORRECTIVE ACTI


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2002-06-03

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