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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEL MEDICAL INC. VS200 WALL STAND; RADIOGRAPHIC CASSETTE HOLDER
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DEL MEDICAL INC. VS200 WALL STAND; RADIOGRAPHIC CASSETTE HOLDER Back to Search Results
Model Number VS200
Device Problem Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/16/2014
Event Type  malfunction  
Manufacturer Narrative
During a recent fda inspection it was observed tht we did not submit a medical device report for additional instances that were already reported.This report is to correct that observation.
 
Event Description
The radiographic technician found a cassette receptor in its lowest position.No injuries were reported.
 
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Brand Name
VS200 WALL STAND
Type of Device
RADIOGRAPHIC CASSETTE HOLDER
Manufacturer (Section D)
DEL MEDICAL INC.
241 covington drive
bloomingdale IL 60108
Manufacturer (Section G)
DEL MEDICAL INC.
241 covington drive
bloomingdale IL 60108
Manufacturer Contact
william kostecki
241 covington drive
bloomingdale, IL 60108
8472887022
MDR Report Key8509834
MDR Text Key146653705
Report Number1418964-2019-00011
Device Sequence Number1
Product Code IXY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Repair
Type of Report Initial
Report Date 04/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVS200
Device Catalogue Number110-5010G1
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received06/16/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/13/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction Number1418964-10/14/15-001-C
Patient Sequence Number1
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