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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC GEL PAD NEONATAL ARCTIC GEL PAD

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MEDIVANCE, INC. ¿ 1725056 ARCTIC GEL PAD NEONATAL ARCTIC GEL PAD Back to Search Results
Catalog Number 318-02
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Abrasion (1689); Ulcer (2274); Vascular System (Circulation), Impaired (2572)
Event Date 11/17/2019
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 neonate had 2 small lesions on back of their head after arctic sun treatment. The hospital personnel did not know if the lesions were from arctic sun gel pad or from poor circulation in the neonate. It is unknown what medical treatment was provided.
 
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Brand NameARCTIC GEL PAD
Type of DeviceNEONATAL ARCTIC GEL PAD
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key9497226
MDR Text Key173276983
Report Number1018233-2019-08100
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeGM
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 01/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number318-02
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 Received01/05/2020
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: 12/19/2019 Patient Sequence Number: 1
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