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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
Catalog Number 317-02
Device Problem Nonstandard Device (1420)
Patient Problems Rash (2033); Skin Discoloration (2074); Skin Inflammation/ Irritation (4545)
Event Date 05/09/2021
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 pad was extremely sticky, hence patient experienced skin redness and irritation where the pads were placed. It took 15mins for 2 nurses to take off the gel pads. Per troubleshooting, user tried to put neonatal or child pad under torso which helped for a couple of hours. But as there was no enough surface area, the pads were reapplied during the night. On 10may21, the pads were again removed and were found to be extremely sticky with skin redness and irritation. It was also noted that there was no skin breakdown and skin was no longer irritated after 2 days off. No medical intervention was reported. Per follow up on 03jun2021, customer stated nothing out of the ordinary as the condition of skin before the pads were applied and it was opened up from a new package. Chg treatment was applied at some point in the day before going on pads as it¿s part of our usual practice for daily treatments. It was not applied right before pad placement and no lotions were used. In bilateral abdomen or sides of torso and upper thighs reddened were located. It looked like the skin was discolored, blistered, scabbed, rash, red, skin irritation. No treatment or wound or skin consult conducted. Customer checked skin were intermittently done, but did not occur more frequently than q8 hours. Patient had no comorbidities that contributed to the patient¿s skin condition. The pads were not placed over any incision or bony surfaces. Patient tried to use neonatal or pediatric pad rather than put the xs adult pads back on, however, that only worked for a period of time and was able to try new set of pads and use at a later time, though they were very sticky as well. No medical intervention was reported.
 
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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 Key12099889
MDR Text Key259398231
Report Number1018233-2021-03967
Device Sequence Number1
Product Code DWJ
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 company representative,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number317-02
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2021
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 Treatment Data
Date Received: 07/01/2021 Patient Sequence Number: 1
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