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MAUDE Adverse Event Report:; LARYNGOSCOPE, RIGID
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; LARYNGOSCOPE, RIGID
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Device Problem
Material Integrity Problem (2978)
Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Date
07/27/2020
Event Type
malfunction
Event Description
The new disposable laryngoscope blades in use are very flimsy and do not adequately lift airway structures.
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Type of Device
LARYNGOSCOPE, RIGID
MDR Report Key
10453280
MDR Text Key
204346859
Report Number
10453280
Device Sequence Number
1
Product Code
CCW
Combination Product (y/n)
N
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
User Facility
Reporter Occupation
Risk Manager
Type of Report
Initial
Report Date
08/18/2020
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
Health Professional
Is the Reporter a Health Professional?
No
Was the Report Sent to FDA?
Yes
Date Report Sent to FDA
08/18/2020
Event Location
Hospital
Date Report to Manufacturer
08/26/2020
Initial Date Manufacturer Received
Not provided
Initial Date FDA Received
08/26/2020
Is This a Reprocessed and Reused Single-Use Device?
No
Type of Device Usage
N
Patient Sequence Number
1
Patient Age
26645 DA
Patient Weight
102
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