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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 ARCTICGEL PADS

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS ARCTICGEL PADS Back to Search Results
Catalog Number 317-07
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/19/2021
Event Type  malfunction  
Event Description
It was reported that the hydrogel got separated from the patch in the arctic gel pads that caused low flow and difficulty of lowering the patient¿s temperature. Hence the pad was changed, and then the device showed that the flow was normal. Per follow up information received on 23nov2021, therapy was completed using another new pads. Customer suspecting potential adhesive issue causing low flow issue. The customer did not face any similar issues in the past. Pads were used on patient and no impact or injury to the patient.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
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Brand NameARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
Type of DeviceARCTICGEL 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 Key12981471
MDR Text Key283834014
Report Number1018233-2021-07950
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number317-07
Device Lot NumberNGFR2298
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/06/2021
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: 12/10/2021 Patient Sequence Number: 1
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