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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERILIZ LLC R-D RAPID DISINFECTOR; DISINFECTOR, MEDICAL DEVICES
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STERILIZ LLC R-D RAPID DISINFECTOR; DISINFECTOR, MEDICAL DEVICES Back to Search Results
Model Number UV-C
Device Problems Self-Activation or Keying (1557); Defective Component (2292)
Patient Problem Eye Injury (1845)
Event Date 02/05/2016
Event Type  malfunction  
Event Description
Employee attempted to disinfect a room.When he plugged in the device, the machine came on by itself and bypassed the safety features.The employee was exposed to the ultraviolet light.The employee complained of eye irritation.The employee received emergency care followed by an ophthalmologist.At this time no further treatment is known.This is the second time this facility has had a problem with this device.The manufacturer was notified.Software version is 4.15.Manufacturer response for uv disinfecting light, r-d rapid disinfector (per site reporter): the manufacturer sent in a replacement machine and is picking up the defective unit today for evaluation.Initially tech support did a series of remote tests and found the machine to be fine.Then it was mentioned that we may need a new lap top computer.The last response was the manufacturer wanted the machine back for further testing.
 
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Brand Name
R-D RAPID DISINFECTOR
Type of Device
DISINFECTOR, MEDICAL DEVICES
Manufacturer (Section D)
STERILIZ LLC
95 allens creek rd
bldg 2 suite 205
rochester NY 14618
MDR Report Key5619249
MDR Text Key44009258
Report Number5619249
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2016
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberUV-C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/21/2016
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer04/21/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
Patient Outcome(s) Other;
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