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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 1; LARYNGOSCOPE, RIGID
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TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 1; LARYNGOSCOPE, RIGID Back to Search Results
Model Number IPN048384
Device Problem Fitting Problem (2183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2021
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
It was reported "customer reported that "failed locking of mac 1 blade on laryngoscope handle.Clinical consequences: had to use larger blade on a child".No patient injury or consequence reported.Patient condition reported as "fine".
 
Event Description
It was reported "customer reported that "failed locking of mac 1 blade on laryngoscope handle.Clinical consequences: had to use larger blade on a child".No patient injury or consequence reported.Patient condition reported as "fine".
 
Manufacturer Narrative
Qn (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.
 
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Brand Name
RUSCH GREENLITE DISP MTL MAC 1
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key12181156
MDR Text Key261978043
Report Number8030121-2021-00025
Device Sequence Number1
Product Code CCW
UDI-Device Identifier14026728626059
UDI-Public14026728626059
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 06/24/2021
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 Date05/01/2024
Device Model NumberIPN048384
Device Catalogue Number004551001
Device Lot Number1906311
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/24/2021
Initial Date FDA Received07/16/2021
Supplement Dates Manufacturer Received07/21/2021
Supplement Dates FDA Received07/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
LARYNGOSCOPE HANDLE; LARYNGOSCOPE HANDLE; LARYNGOSCOPE HANDLE
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