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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RIGID YANKAUER SET 10'; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
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RIGID YANKAUER SET 10'; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED Back to Search Results
Model Number 8888505040
Medical Device Problem Code Sharp Edges (4013)
Health Effect - Clinical Code Laceration(s) (1946)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event or Problem Description
The customer reported that they had a patient end up with wounds behind their mouth after using this suction tip.The suction tip has holes on the side near the tip that are cut so that the edges of the holes are sharp.
 
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Brand Name
RIGID YANKAUER SET 10'
Common Device Name
APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
MDR Report Key12738904
Report Number9612030-2021-03073
Device Sequence Number13812995
Product Code GCX
UDI-Device Identifier10884527019977
UDI-Public10884527019977
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/02/2021
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
Operator of Device No Information
Device Model Number8888505040
Device Catalogue Number8888505040
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/19/2021
Initial Report FDA Received Date11/02/2021
Is the Device Labeled for Single Use? (Y/N) Yes
Usage of Device N
Patient Sequence Number1
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