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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICSUN GEL PADS; ARCTIC SUN GEL PADS
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MEDIVANCE, INC. ¿ 1725056 ARCTICSUN GEL PADS; ARCTIC SUN GEL PADS Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Sepsis (2067); No Consequences Or Impact To Patient (2199); Skin Tears (2516); Fluid Discharge (2686)
Event Type  Injury  
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 there was a patient-device incompatibility on the arctic sun device.There was a palm sized skin tear from the arctic sun pads with serous drainage.The patient was 3rd spacing from possible sepsis which was a contributing factor.Per follow up, therapy was not completed on the device and the device was not swapped.
 
Event Description
It was reported that there was a patient-device incompatibility on the arctic sun device.There was a palm sized skin tear from the arctic sun pads with serous drainage.The patient was 3rd spacing from possible sepsis which was a contributing factor.Per follow up, therapy was not completed on the device and the device was not swapped.
 
Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿excessive adhesive force strength¿.A potential root cause for this failure could be "inherent by design ¿ mechanical properties of the hydrogel formulation".The lot number is unknown; therefore, the device history record could not be reviewed.The product code for this z300-unknown articgel pads product is unknown.Therefore, bd is unable to determine the associated labeling to review.Although the product code is unknown, the z300-unknown articgel pads product labeling is found to be adequate based on past reviews.Correction: b2 h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
 
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Brand Name
ARCTICSUN GEL PADS
Type of Device
ARCTIC SUN GEL PADS
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key9607088
MDR Text Key187229790
Report Number1018233-2020-00429
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 02/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received02/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age75 YR
Patient Weight66
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