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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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS Back to Search Results
Model Number 31705
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2022
Event Type  malfunction  
Event Description
It was reported that when the customer peeled of the film and tried to use the artic gel pads, the adhesive layer was attached to the film side instead of the pad side (lot# ngfr5281). It seemed that there had been similar cases in the past (lot# unk) and the patient had used it. Per follow up information received via ibc on 11mar2022, it was stated that the past event was not reported and the detail was unknown.
 
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
juan velez
8195 industrial blvd
covington 30014
7707846100
MDR Report Key13966885
MDR Text Key288309260
Report Number1018233-2022-01826
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080067
UDI-Public(01)00801741080067
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number31705
Device Catalogue Number317-05
Device Lot NumberNGFR5281
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/29/2022
Was Device Evaluated by Manufacturer? No
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: 03/31/2022 Patient Sequence Number: 1
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