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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIRCRAFT MEDICAL LIMITED MCGRATH; LARYNGOSCOPE, RIGID
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AIRCRAFT MEDICAL LIMITED MCGRATH; LARYNGOSCOPE, RIGID Back to Search Results
Model Number 300-000-000
Device Problem Use of Device Problem (1670)
Patient Problem Extubate (2402)
Event Date 09/16/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the endotracheal tube/the tip was detached.Reintubation was required.
 
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Brand Name
MCGRATH
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
AIRCRAFT MEDICAL LIMITED
7 cross way
dalgety bay,fi KY11 9JE
GB  KY11 9JE
Manufacturer (Section G)
AIRCRAFT MEDICAL LIMITED
7 cross way
dalgety bay,fi KY11 9JE
GB   KY11 9JE
Manufacturer Contact
avi kluger
5920 longbow drive
boulder, CO 80301
3035306582
MDR Report Key9293658
MDR Text Key165573152
Report Number3010244187-2019-00024
Device Sequence Number1
Product Code CCW
UDI-Device Identifier15060272980020
UDI-Public15060272980020
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number300-000-000
Device Catalogue Number300-000-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/23/2019
Initial Date FDA Received11/07/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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