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 2009-12-17 for PROGENY PREVA P7016 manufactured by Midmark Corporation.

Event Text Entries

[19459319] A service tech from the distributor reported that the mechanical structure of a preva intraoral unit, (b) (4), separated from its wall mount at (b) (6) dental office. No injury reported.
Patient Sequence No: 1, Text Type: D, B5


[19714798] Conclusion: improper installation: the 3" long lag screws used to attach the wall mount were too short due to the fact that there are 2 layers of sheetrock. The thick sheetrock prevented the lag screws from getting a good grip in the wood studs. The installation manual points out that "progeny provides fasteners for average installations. Based on specific installation condition, it may be necessary to choose an alternate fastener or fastening methods".
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1423380-2009-00028
MDR Report Key1575527
Report Source08
Date Received2009-12-17
Date of Report2009-12-15
Date of Event2009-11-25
Date Mfgr Received2009-11-25
Device Manufacturer Date2007-09-01
Date Added to Maude2010-07-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 Phone8474159800
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROGENY PREVA
Product CodeMUH
Date Received2009-12-17
Model NumberPREVA
Catalog NumberP7016
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMIDMARK CORPORATION
Manufacturer Address675 HEATHROW DR. LINCOLNSHIRE IL 60069 US 60069


Patients

Patient NumberTreatmentOutcomeDate
10 2009-12-17

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