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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DORNOCH MEDICAL DUO FLEX FLUID CART SMOKE
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DORNOCH MEDICAL DUO FLEX FLUID CART SMOKE Back to Search Results
Catalog Number UL-DU500SE
Device Problem Use of Device Problem (1670)
Patient Problem Injury (2348)
Event Date 06/05/2015
Event Type  malfunction  
Event Description
It was reported from employee health at the user facility that a hospital staff member cut her finger while cleaning the duo flex fluid cart with smoke evacuator.It was stated that the individual cut her finger on the lip of the cl housing while wiping down the unit.The customer inquired about potential exposure.Despite multiple follow up attempts with the customer, no additional information was received prior to this report.If additional information is received, a follow up medwatch will be submitted.
 
Manufacturer Narrative
The device was installed on (b)(6) 2015 and has no repair history with zimmer.The device was not made available for evaluation or repair by zimmer.The customer's reported event could not be confirmed and a cause could not be determined.
 
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Brand Name
DUO FLEX FLUID CART SMOKE
Type of Device
DUO FLEX FLUID CART SMOKE
Manufacturer (Section D)
DORNOCH MEDICAL
200 nw pkwy rd.
riverside MO 64150
Manufacturer Contact
kathleen smith
200 nw pkwy. rd.
riverside, MO 64150
3303438801
MDR Report Key4874027
MDR Text Key6043603
Report Number1954182-2015-00002
Device Sequence Number1
Product Code FLH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Unknown
Type of Report Initial
Report Date 06/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUL-DU500SE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/05/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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