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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000; ARCTIC SUN DEVICE
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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000; ARCTIC SUN DEVICE Back to Search Results
Catalog Number 5000-01-02
Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)
Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the arctic sun device was leaking and was not reported to have been related to patients.
 
Manufacturer Narrative
Upon further review, bard/bd medical has determined that this mdr was initially reported in error as this event is not reportable.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
It was reported that the arctic sun device was leaking and was not reported to have been related to patients.
 
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Brand Name
ARCTIC SUN 5000
Type of Device
ARCTIC SUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key10494998
MDR Text Key206963168
Report Number1018233-2020-05713
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
PMA/PMN Number
K161602
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 04/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5000-01-02
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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