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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICGEL PADS

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MEDIVANCE, INC. ¿ 1725056 ARCTICGEL PADS Back to Search Results
Catalog Number 317-00
Device Problems Inaccurate Flow Rate (1249); Inadequacy of Device Shape and/or Size (1583)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
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 a (b)(6) old patient was below the target temperature at 30. 3c. The water temperature of the device was 15c. The nurse believed she was using a universal small pad, but later found that it was an adult universal pad. The flow rate was 0. 3lpm with the adult universal pad and once the pad was switched to the correct size, the flow rate was 1. 2lpm.
 
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Brand NameARCTICGEL PADS
Type of DeviceGEL PAD
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key8752758
MDR Text Key151620815
Report Number1018233-2019-03502
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 health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number317-00
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 Received07/31/2019
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

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