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MAUDE Adverse Event Report: MEDTRONIC USA NUVENT
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MEDTRONIC USA NUVENT
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Model Number
1830707MAX
Device Problem
Burst Container or Vessel (1074)
Patient Problem
No Consequences Or Impact To Patient (2199)
Event Date
11/18/2016
Event Type
malfunction
Event Description
During a sinus procedure, product balloon inflated and popped on right side.
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Brand Name
NUVENT
Type of Device
NUVENT
Manufacturer
(Section D)
MEDTRONIC USA
MDR Report Key
6173418
MDR Text Key
62550747
Report Number
MW5066680
Device Sequence Number
1
Product Code
LRC
Reporter Country Code
US
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
Voluntary
Reporter Occupation
Other Health Care Professional
Type of Report
Initial
Report Date
12/09/2016
1
Device was Involved in the Event
1
Patient was Involved in the Event
Date FDA Received
12/09/2016
Is this an Adverse Event Report?
No
Is this a Product Problem Report?
Yes
Device Operator
Health Professional
Device Model Number
1830707MAX
Was Device Available for Evaluation?
Device Returned to Manufacturer
Date Returned to Manufacturer
11/18/2016
Is the Reporter a Health Professional?
Yes
Is This a Reprocessed and Reused Single-Use Device?
Yes
Type of Device Usage
N
Patient Sequence Number
1
Treatment
NUVENT MAXILLARY BALLOON 7MM
Patient Age
15 YR
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