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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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/27/2015
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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