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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAKO NORTH AMERICA, INC. AUTOSTAINER LINK 48

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DAKO NORTH AMERICA, INC. AUTOSTAINER LINK 48 Back to Search Results
Model Number AS480
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/27/2020
Event Type  malfunction  
Event Description
Summary: based on complaint report or investigated failure mode, there was potential for a staining alteration.Customer complaint record reported the event as follows: insufficient bulk fluids may have affected aspirations.No direct or indirect patient harm, or user harm have been reported.
 
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Brand Name
AUTOSTAINER LINK 48
Type of Device
AUTOSTAINER LINK 48
Manufacturer (Section D)
DAKO NORTH AMERICA, INC.
6392 via real
carpinteria CA 93013
Manufacturer (Section G)
DAKO NORTH AMERICA, INC.
6392 via real
carpinteria CA 93013
Manufacturer Contact
mani siravanta
6392 via real
carpinteria, CA 93013
8055665462
MDR Report Key10583962
MDR Text Key208986680
Report Number2022180-2020-00336
Device Sequence Number1
Product Code KPA
UDI-Device Identifier05700572035497
UDI-Public05700572035497
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/24/2020
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 Health Professional
Device Model NumberAS480
Device Catalogue NumberAS48030
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/27/2020
Initial Date FDA Received09/24/2020
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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