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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC ACCUMIST BLOWER/MISTER; LAVAGE, JET

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MEDTRONIC ACCUMIST BLOWER/MISTER; LAVAGE, JET Back to Search Results
Model Number 29150
Device Problem Material Rupture (1546)
Patient Problem No Information (3190)
Event Date 08/07/2017
Event Type  malfunction  
Event Description
Tubing ruptured approximately 8 inches from hand piece during the procedure.
 
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Brand Name
ACCUMIST BLOWER/MISTER
Type of Device
LAVAGE, JET
Manufacturer (Section D)
MEDTRONIC
MDR Report Key6800138
MDR Text Key82992399
Report NumberMW5071611
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/14/2017
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
Device Model Number29150
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/14/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age59 YR
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