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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 4; LARYNGOSCOPE, RIGID
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TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 4; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 004551004
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 01/01/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer complaint alleges "the blade is broken so it cannot be used." alleged issue reported occurred prior to patient use when the package was opened.It was reported there was no patient involvement.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
Customer complaint alleges "the blade is broken so it cannot be used." alleged issue reported occurred prior to patient use when the package was opened.It was reported there was no patient involvement.
 
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Brand Name
RUSCH GREENLITE DISP MTL MAC 4
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key8253238
MDR Text Key133339581
Report Number8030121-2019-00002
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date08/01/2023
Device Catalogue Number004551004
Device Lot Number1809341
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/03/2019
Initial Date FDA Received01/16/2019
Supplement Dates Manufacturer Received02/18/2019
Supplement Dates FDA Received02/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.
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