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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 31707
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2022
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 right leg arctic gel pad was not available because the adhesive surface and the pad was separated. The customer was able to continue the target temperature management treatment by changing the defective right & left leg pad with another lot number. The other parts of the pad (lot# ngfx1264) were already attached to the patient, so only the lower pad (right & left leg pad) with the problem was returned. Also, the customer sent the remaining parts (lot# ngfx3727) of the replaced lot. Per follow up information received on 17mar2022, it was stated that there was no patient involvement. This issue occurred before use. The therapy was completed with different replaced arctic gel pad.
 
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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 Key14525741
MDR Text Key293077525
Report Number1018233-2022-04189
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080081
UDI-Public(01)00801741080081
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number31707
Device Catalogue Number317-07-02
Device Lot NumberNGFX1264
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/06/2021
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: 05/27/2022 Patient Sequence Number: 1
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