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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACCLARENT, INC. ACCLARENT SE; INSTRUMENT, ENT MANUAL SURGICAL
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ACCLARENT, INC. ACCLARENT SE; INSTRUMENT, ENT MANUAL SURGICAL Back to Search Results
Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/30/2017
Event Type  malfunction  
Event Description
The se inflation device had a leak at the neck where the balloon and eustachian tube connect.Disposable device malfunctioned.Patient was not harmed, new device opened and used.Preoperative diagnoses: obstructive left nasal septal deviation and turbinate hypertrophy, secondary to nasal trauma.Bilateral inferior turbinate hypertrophy.Nasal fracture, right lateral wall.Postoperative diagnoses: obstructive left nasal septal deviation and turbinate hypertrophy, secondary to nasal trauma.Bilateral inferior turbinate hypertrophy.Nasal fracture, right lateral wall.Name of operation: endoscopic septoplasty.Bilateral inferior coblation turbinectomy.Closed reduction of right lateral nasal wall fracture.
 
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Brand Name
ACCLARENT SE
Type of Device
INSTRUMENT, ENT MANUAL SURGICAL
Manufacturer (Section D)
ACCLARENT, INC.
33 technology dr
irvine CA 92618
MDR Report Key6739804
MDR Text Key80908254
Report Number6739804
Device Sequence Number1
Product Code LRC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Unknown
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/05/2017
Event Location Hospital
Date Report to Manufacturer07/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
Patient Age74 YR
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