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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
Model Number 38301
Device Problems Expiration Date Error (2528); Device Handling Problem (3265)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2022
Event Type  malfunction  
Event Description
It was reported that small set of arctic gel pads were opened and gel came off from the pad rendering it unusable.Nurse replaced with universal pad for therapy.Nurse noticed petechiae on skin under pads after removal.The nurse noted that the universal pads were expired but unable to confirm expiration date of the pads used.Multiple adjustments were made to device during therapy.Per follow up information received via email on 14apr2022, the lot number was ngen0469.The petechia was found across the patient abdominal area.The skin condition before pads were applied was clear with no issues.The therapy was stopped into 7 hours of rewarming phase.No medical intervention was taken, the pads were removed from patient and they continued to monitor.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that small set of arctic gel pads were opened and gel came off from the pad rendering it unusable.Nurse replaced with universal pad for therapy.Nurse noticed petechiae on skin under pads after removal.The nurse noted that the universal pads were expired but unable to confirm expiration date of the pads used.Multiple adjustments were made to device during therapy.Per follow up information received via email on 14apr2022, the lot number was ngen0469.The petechia was found across the patient abdominal area.The skin condition before pads were applied was clear with no issues.The therapy was stopped into 7 hours of rewarming phase.No medical intervention was taken, the pads were removed from patient and they continued to monitor.
 
Manufacturer Narrative
Upon further review, bd has determined this event is not reportable.The information provided does not reasonably suggest that the event may have caused or contributed to a reportable malfunction of the device or a death/serious injury of a patient, user or other person.Therefore this event is deemed not reportable per 21 cfr part 803.Pminnarasi 11jul2022.H3 other text : the device was not returned.
 
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Brand Name
ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
Type of Device
ARCTIC 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
juan velez
8195 industrial blvd
covington 30014
7707846100
MDR Report Key14309642
MDR Text Key290952978
Report Number1018233-2022-03384
Device Sequence Number1
Product Code NNX
UDI-Device Identifier00801741071225
UDI-Public(01)00801741071225
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/31/2022
Device Model Number38301
Device Catalogue Number317-00-04
Device Lot NumberNGEN0469
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/12/2022
Initial Date FDA Received05/06/2022
Supplement Dates Manufacturer Received06/29/2022
Supplement Dates FDA Received07/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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