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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS ARCTIC GEL PADS

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS ARCTIC GEL PADS Back to Search Results
Catalog Number 317-09
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2021
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 gel pads did not stick as there was no hydro-gel. It was stated that the device was still in place on a patient in the cardiovascular intensive care unit with the installation of a "do-it-yourself" system to hold the patient in.
 
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Brand NameARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS
Type of DeviceARCTIC GEL PADS
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key11608310
MDR Text Key243573560
Report Number1018233-2021-01827
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2022
Device Catalogue Number317-09
Device Lot NumberNGEX1056
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/02/2021 Patient Sequence Number: 1
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