• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDIVANCE, INC. ¿ 1725056 ARCTICSUN GEL PADS Back to Search Results
Model Number 50000000
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Burn, Thermal (2530); Patient Problem/Medical Problem (2688)
Event Type  Injury  
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 patient experienced a thermal injury while on the arcticsun device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARCTICSUN GEL PADS
Type of DeviceARCTICSUN GEL PADS
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 Key8683987
MDR Text Key147522931
Report Number1018233-2019-03001
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080142
UDI-Public(01)00801741080142
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 07/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number50000000
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 Received07/15/2019
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

Patient Treatment Data
Date Received: 06/10/2019 Patient Sequence Number: 1
-
-