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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREEN RUSCHLITE DISP MTL MAC 3; LARYNGOSCOPE, RIGID
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TELEFLEX MEDICAL RUSCH GREEN RUSCHLITE DISP MTL MAC 3; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 004551003
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 05/27/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A visual, functional and dimensional inspection could not be conducted since the device sample was not available for evaluation.The complaint cannot be confirmed.The root cause cannot be determined.No corrective/preventative actions will be assigned.No further action required.
 
Event Description
The customer alleges that the device was broken within the package.
 
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Brand Name
RUSCH GREEN RUSCHLITE DISP MTL MAC 3
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville NC 27560
Manufacturer Contact
margie burton, rn
3015 carrington mill blvd
morrisville, NC 27560
9194334965
MDR Report Key5722645
MDR Text Key47307182
Report Number3011137372-2016-00161
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 Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number004551003
Device Lot Number1601332
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/27/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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