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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERROSAN MEDICAL DEVICES AS SURGIFOAM POWDER KIT
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FERROSAN MEDICAL DEVICES AS SURGIFOAM POWDER KIT Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Renal Failure (2041)
Event Type  Injury  
Event Description
A spine surgeon used surgifoam powder kit and reported through the sales rep that 3 recent pts were negatively impacted with acute renal failure and he thinks that it is form the product.Pt 1: (b)(6) / pi1-rufvk4.
 
Event Description
A spine surgeon used surgifoam powder kit and reported through the sales rep that 3 recent pts were negatively impacted with acute renal failure and he thinks that it is form the product.Pt 2: (b)(6)/ pi1-ruh406.
 
Event Description
A spine surgeon used surgifoam powder kit and reported through the sales rep that 3 recent pts were negatively impacted with acute renal failure and he thinks that it is form the product.Pt 3: (b)(6) / pi1-rui75j.
 
Manufacturer Narrative
A number of clinical questions has been asked to clarify the event.This is our final eval of these events.
 
Manufacturer Narrative
A number of clinical questions has been asked to clarify the event.This is our final eval of these events.
 
Manufacturer Narrative
A number of clinical questions has been asked to clarify the event.This is our final eval of these events.
 
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Brand Name
SURGIFOAM POWDER KIT
Type of Device
SURGIFOAM POWDER KIT
Manufacturer (Section D)
FERROSAN MEDICAL DEVICES AS
Manufacturer Contact
sydmarken 5
soeborg 2860
MDR Report Key4755214
MDR Text Key5789623
Report Number3008478369-2015-00004
Device Sequence Number1
Product Code LMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Unknown
Reporter Occupation Other
Type of Report Initial
Report Date 03/10/2015
1 Device was Involved in the Event
3 Patient was Involved in the Event
Date FDA Received04/27/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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