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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMBU, INC. AURASTRAIGHT; AIRWAY, OROPHARANGEAL

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AMBU, INC. AURASTRAIGHT; AIRWAY, OROPHARANGEAL Back to Search Results
Catalog Number 324 300 000 U
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Discomfort (2330); Injury (2348)
Event Date 07/02/2018
Event Type  malfunction  
Event Description
Pt sustained an injury to left knee and has suffered pain & discomfort.General anesthesia was administered via lma (laryngeal mask airway).However, patient needed to be intubated because the lma (new green one) was not securing airway correctly.Anesthesia was very concerned since lma brand was switched last month and this is a recurring problem.
 
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Brand Name
AURASTRAIGHT
Type of Device
AIRWAY, OROPHARANGEAL
Manufacturer (Section D)
AMBU, INC.
6230 old dobbin ln ste 250
columbia MD 21045
MDR Report Key7768136
MDR Text Key116657533
Report Number7768136
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number324 300 000 U
Device Lot Number1000054203
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/13/2018
Event Location Hospital
Date Report to Manufacturer08/02/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age14235 DA
Patient Weight168
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