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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HU-FRIEDY MFG. CO. LLC SWIVEL DIRECT FLOW; SCALER, ULTRASONIC
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HU-FRIEDY MFG. CO. LLC SWIVEL DIRECT FLOW; SCALER, ULTRASONIC Back to Search Results
Model Number UI30SD100
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/29/2019
Event Type  Injury  
Event Description
During a scaling and root planing (srp) procedure, the tip of an instrument broke in a patient's mouth and was swallowed.The patient was referred to the er and it was reported to image dental that the patient was examined and told the tip would pass on its own.
 
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Brand Name
SWIVEL DIRECT FLOW
Type of Device
SCALER, ULTRASONIC
Manufacturer (Section D)
HU-FRIEDY MFG. CO. LLC
3232 n rockwell st
chicago IL 60618
Manufacturer (Section G)
HU-FRIEDY MFG. CO. LLC
3232 n rockwell st
chicago IL 60618
Manufacturer Contact
matt berns
3232 n rockwell st
chicago, IL 60618
MDR Report Key8719305
MDR Text Key148802462
Report Number1416605-2019-00012
Device Sequence Number1
Product Code ELC
UDI-Device Identifier10889950075620
UDI-Public(01)10889950075620(10)1116
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K012060
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberUI30SD100
Device Catalogue NumberUI30SD100
Device Lot Number11/16
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2019
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age24 YR
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