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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIDMARK CORPORATION VETPRO DC MOBILE SYSTEM; UNIT, X-RAY, EXTRAORAL WITH TIMER
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MIDMARK CORPORATION VETPRO DC MOBILE SYSTEM; UNIT, X-RAY, EXTRAORAL WITH TIMER Back to Search Results
Model Number VETPRO DC
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Numbness (2415); Electric Shock (2554)
Event Date 05/27/2015
Event Type  malfunction  
Event Description
On (b)(6) 2015, it was reported to midmark by a veterinary user facility that a veterinary assistant ("mb") experienced electrical shock while using the hand-held exposure switch during the operation of a vetpro dc mobile x-ray device.Mb reported that her arm went numb when the electrical shock occured.No medical treatment was sought.
 
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Brand Name
VETPRO DC MOBILE SYSTEM
Type of Device
UNIT, X-RAY, EXTRAORAL WITH TIMER
Manufacturer (Section D)
MIDMARK CORPORATION
675 heathrow dr.
lincolnshire IL 60069
Manufacturer Contact
adam foresman
675 heathrow drive
lincolnshire, IL 60069
8474159739
MDR Report Key4869950
MDR Text Key6064793
Report Number1423380-2015-00017
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberVETPRO DC
Device Catalogue NumberP7017VM
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/27/2015
Initial Date FDA Received06/25/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/14/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/13/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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