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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDMARK CORPORATION PROGENY PREVA; UNIT, X-RAY, EXTRAORAL WITH TIMER
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MEDMARK CORPORATION PROGENY PREVA; UNIT, X-RAY, EXTRAORAL WITH TIMER Back to Search Results
Model Number PREVA
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/25/2014
Event Type  malfunction  
Event Description
The field service tech of a distributor reported to midmark that during the installation of a preva x-ray unit, serial number (b)(4), when he carried the arm and tube head assembly, the tie wrap that ties the articulating arms together broke.The arms expanded and came near the right side of his face.The field service tech confirmed that there was no injury.
 
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Brand Name
PROGENY PREVA
Type of Device
UNIT, X-RAY, EXTRAORAL WITH TIMER
Manufacturer (Section D)
MEDMARK CORPORATION
675 heathrow drive
lincolnshire IL 60089
Manufacturer (Section G)
MIDMARK CORPORATION
675 heathrow drive
lincolnshire IL 60069
Manufacturer Contact
peng lin
675 heathrow drive
lincolnshire, ID 60065
8474159787
MDR Report Key3820219
MDR Text Key4446895
Report Number1423380-2014-00002
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 Distributor
Reporter Occupation Service Personnel
Type of Report Initial
Report Date 04/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberPREVA
Device Catalogue NumberP7017-P
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/01/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received03/25/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2013
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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