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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MISONIX, INC. BONESCALPEL; INSTRUMENT, ULTRASONIC SURGICAL

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MISONIX, INC. BONESCALPEL; INSTRUMENT, ULTRASONIC SURGICAL Back to Search Results
Catalog Number MXB-T
Device Problem Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 03/31/2021
Event Type  malfunction  
Event Description
The tubing leaked when spiked.
 
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Brand Name
BONESCALPEL
Type of Device
INSTRUMENT, ULTRASONIC SURGICAL
Manufacturer (Section D)
MISONIX, INC.
1938 new highway
farmingdale NY 11735
MDR Report Key11862236
MDR Text Key251906242
Report Number11862236
Device Sequence Number1
Product Code LFL
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 05/17/2021
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 Catalogue NumberMXB-T
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/17/2021
Event Location Hospital
Date Report to Manufacturer05/21/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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