SONESTA 6205 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-04-08 for SONESTA 6205 * manufactured by Stille-sonesta Inc.

Event Text Entries

[368592] While transferring a patient to a urology table, the patient was temporarily positioned on the table extension. At this moment, the patient's movements caused the extension to separate from the rest of the table. The patient slid off of the table extension receiving an abrasion. A clinician attempting to catch the patient was bruised.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number590473
MDR Report Key590473
Date Received2005-04-08
Date of Report2005-04-01
Date of Event2005-01-28
Report Date2005-04-01
Date Reported to FDA2005-04-08
Date Added to Maude2005-04-14
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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 Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameSONESTA
Generic NameTABLE, FLUOROSCOPY
Product CodeMMZ
Date Received2005-04-08
Model Number6205
Catalog Number*
Lot Number*
ID Number*
OperatorNURSE
Device AvailabilityY
Device Age1 YR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key580323
ManufacturerSTILLE-SONESTA INC
Manufacturer Address2220 CANTON SUITE 209 DALLAS TX 75201 US

Device Sequence Number: 2

Brand NameVIDEO FLUOROSCOPY TABLE EXTENSION
Generic NameTABLE EXTENSION
Product CodeMMZ
Date Received2005-04-08
Model Number*
Catalog Number*
Lot Number*
ID Number*
Implant FlagN
Date Removed*
Device Sequence No2
Device Event Key580324
ManufacturerSTILLE- SONESTA
Manufacturer Address2220 CANTON, 209 DALLAS TX 75201 US

Patients

Patient NumberTreatmentOutcomeDate
10 2005-04-08
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