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

Catalog Number UNKNOWN

Device Problem Biocompatibility (2886)

Patient Problems Burn(s) (1757); Skin Irritation (2076)

Event Date 06/15/2020

Event Type  Injury  

Manufacturer Narrative

The reported issue could not be confirmed.No sample was returned for evaluation.A potential root cause for this failure could be " (2.3.5) pads placed on top of muscle flap, skin flap, scars, implants, or bony protuberance".The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, labeling review could not be performed.The device was not returned.

Event Description

It was reported that the patient experienced skin irritations, skin damage & skin burned using the arcticgel pads.The customer further reported that nearly 60% of all patients using arctic sun in their hospital (located in their icu unit) are experiencing skin damages, burns and irritations.Before applying the arctic sun pads, the customer cleans the patients with wet wipes.The wipes are previously soaked in a water/alcohol solution.Sales rep believes these events are use-error related and was scheduling to visit the hospital to check how they are using the device, and train them accordingly.Per additional information via e-mail on 18jun2020, no medical intervention other than nurse care was needed.

• Brand Name: UNKNOWN ARCTICGEL PADS
• Type of Device: UNKNOWN ARCTICGEL 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 Key: 10245338
• MDR Text Key: 197961194
• Report Number: 1018233-2020-04380
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/08/2020
• 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 Sequence Number: 1
• Patient Outcome(s): Other