765DC INTRAORAL X-RAY SYSTEM 110-0154G3 A0765DC75

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-04-12 for 765DC INTRAORAL X-RAY SYSTEM 110-0154G3 A0765DC75 manufactured by Gendex Imaging.

Event Text Entries

[20617152] Assistant lined up the pt with the rinn holder and the arm snapped and hit the pt on the left side of her face. Pt was cut on the face.
Patient Sequence No: 1, Text Type: D, B5


[20826376] Conclusion: defective scissors arm. Scissor arm and tubehead replaced.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1419798-2007-00012
MDR Report Key842004
Report Source05
Date Received2007-04-12
Date of Report2007-04-02
Date of Event2007-03-29
Date Mfgr Received2007-04-02
Device Manufacturer Date2001-05-01
Date Added to Maude2007-04-30
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 FDA3
Event Location0
Manufacturer ContactJOHN MILLER, DIR
Manufacturer Street901 W OAKTON ST
Manufacturer CityDES PLAINES IL 60018
Manufacturer CountryUS
Manufacturer Postal60018
Manufacturer Phone8473643931
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name765DC INTRAORAL X-RAY SYSTEM
Generic NameDIAGNOSTIC X-RAY UNIT
Product CodeEAP
Date Received2007-04-12
Model Number110-0154G3
Catalog NumberA0765DC75
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key829279
ManufacturerGENDEX IMAGING
Manufacturer Address901 W OAKTON ST DES PLAINES IL 60018 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2007-04-12

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