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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDICAL DEVICES EVALUMEND; LARYNGOSCOPE
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MEDICAL DEVICES EVALUMEND; LARYNGOSCOPE Back to Search Results
Model Number 3-01B8-53
Device Problem Light Interference (2972)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/16/2018
Event Type  malfunction  
Manufacturer Narrative
Customer did return affected devices, the investigation results can partially confirm some of the affected product returned.There was damage to the handles unsure if this occurred during use over the years or through re-processing handles using sterrad treatment.A nc will be issued for further investigation.The devices were not an out of the box failure, devices were processed for over 5 year, in which devices may have been processed incorrectly over the course of several year.This is statement based on the original invoice (po) and product lot numbers.
 
Event Description
The customer alleges that "handles would not light after sterrad treatment." no other details were provided and no patient injury/harm reported.
 
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Brand Name
EVALUMEND
Type of Device
LARYNGOSCOPE
Manufacturer (Section D)
MEDICAL DEVICES
wazirabad road, ugoki.
sialkot punjab, pakistan
MDR Report Key7356732
MDR Text Key103006403
Report Number1036445-2018-00009
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number3-01B8-53
Device Lot NumberNB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/22/2018
Type of Device Usage N
Patient Sequence Number1
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