PROGENY PREVA P7017

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 2010-05-04 for PROGENY PREVA P7017 manufactured by Midmark Corp.

Event Text Entries

[16164689] A technical support from dealer reported that the mechanical structure of a preva intra-oral x-ray unit, (b)(4), separated from the wall. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1423380-2010-00004
MDR Report Key1679314
Report Source08
Date Received2010-05-04
Date of Report2010-04-29
Date of Event2010-04-05
Date Mfgr Received2010-04-05
Device Manufacturer Date2009-02-24
Date Added to Maude2010-09-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactLISA BARTAKOVICS
Manufacturer Street675 HEATHROW DR
Manufacturer CityLINCOLNSHIRE IL 60069
Manufacturer CountryUS
Manufacturer Postal60069
Manufacturer Phone8474159763
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROGENY PREVA
Product CodeMUH
Date Received2010-05-04
Model NumberPREVA
Catalog NumberP7017
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMIDMARK CORP
Manufacturer Address675 HEATHROW DR LINCOLNSHIRE IL 60069 US 60069


Patients

Patient NumberTreatmentOutcomeDate
10 2010-05-04

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