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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL CONSIGNED 115V DOMESTIC HOTLINE

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NULL CONSIGNED 115V DOMESTIC HOTLINE Back to Search Results
Model Number CON-HL-90
Device Problem Defective Component (2292)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Narrative 1.
 
Event Description
Information was received indicating that a smiths medical product was suspected of having a bad micro switch.There were no reported adverse events.
 
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Brand Name
CONSIGNED 115V DOMESTIC HOTLINE
Manufacturer (Section G)
NULL
MDR Report Key10057555
MDR Text Key191269657
Report Number3012307300-2020-04427
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K911383
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 05/14/2020
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 No Information
Device Model NumberCON-HL-90
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/10/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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