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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 NEONATAL ARTICGEL PADS ARCTICSUN GEL PADS Back to Search Results
Catalog Number 318-02
Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)
Patient Problems Ischemia (1942); Rash (2033); Skin Irritation (2076); Tissue Damage (2104); Skin Inflammation (2443); Patient Problem/Medical Problem (2688)
Event Date 02/17/2019
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 after 24 hours of the therapy, it was observed by the nurse (b)(6), lesions in bilateral armpits. Hyperemia-like lesions, dermis rupture and epidermal involvement with small ischemia point. It was observed that as the bed needs to be slightly tilted at a 15 ° angle. The baby "slipped" on the pad, causing continuous pressure between the armpits and the extremities of the abdominal band.
 
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Brand NameNEONATAL ARTICGEL 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 Key8422414
MDR Text Key138851379
Report Number1018233-2019-01315
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeBR
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,Followup
Report Date 04/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2019
Device Catalogue Number318-02
Device Lot NumberNGCPY607
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/14/2019 Patient Sequence Number: 1
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