PROGENY PREVA P7016

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 2010-06-11 for PROGENY PREVA P7016 manufactured by Midmark Corporation.

Event Text Entries

[1563498] A service technician 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


[8563083] Results: the x-ray unit was mounted in a center island cabinet. The backing of the cabinet was not strong enough.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1423380-2010-00015
MDR Report Key1755365
Report Source08
Date Received2010-06-11
Date of Report2010-06-11
Date of Event2010-05-21
Date Mfgr Received2010-05-21
Device Manufacturer Date2010-02-01
Date Added to Maude2011-02-04
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 Received2010-06-11
Returned To Mfg2010-06-01
Model NumberPREVA
Catalog NumberP7016
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMIDMARK CORPORATION
Manufacturer Address675 HEATHROW DRIVE LINCOLNSHIRE IL 60069 US 60069


Patients

Patient NumberTreatmentOutcomeDate
10 2010-06-11

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