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

Catalog Number UNKNOWN

Device Problem Inaccurate Flow Rate (1249)

Patient Problem Skin Discoloration (2074)

Event Date 03/27/2021

Event Type  malfunction  

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 was concerned about the water temperature that was dropped to 4c and skin was red.The goal temperature was 36c and patient temperature was 36.8c.The user changed low water limit to 10c which was current water temperature and flow rate was 1.6 l/m.Patient experienced shivering and told shivering was likely culprit and to address.Patient had only 3 pads on due to below knee amputation.Mss suggested attaching 4th pad to optimize flow and would talk to managing director about shivering control.Explained brief red skin that was blanchable and it was fine to leave water with low temperature at 10c, if it makes the user more comfortable.The nurse would monitor the skin and call back if patient was not back to goal soon.

Event Description

It was reported that the patient was concerned about the water temperature that was dropped to 4c and skin was red.The goal temperature was 36c and patient temperature was 36.8c.The user changed low water limit to 10c which was current water temperature and flow rate was 1.6 l/m.Patient experienced shivering and told shivering was likely culprit and to address.Patient had only 3 pads on due to below knee amputation.Mss suggested attaching 4th pad to optimize flow and would talk to managing director about shivering control.Explained brief red skin that was bleachable and it was fine to leave water with low temperature at 10c, if it makes the user more comfortable.The nurse would monitor the skin and call back if patient was not back to goal soon.Per follow up 1on 30mar2021 via nurse (b)(6), patient was still slow to cool.Low water limit remained at 10c, so the nurse thinks that was the reason the patient was still cooling slowly.Therapy completed this morning with no further issues.No other information available.Per follow up via nurse (b)(6) on 20apr2021, mss helped to resolve issue.Pads were disposed of after use.

Manufacturer Narrative

Per follow up information received, it has been determined that this event is not reportable.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: UNKNOWN ARCTICGEL PADS
• Type of Device: UNKNOWN ARCTICGEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• MDR Report Key: 11692922
• MDR Text Key: 246280346
• Report Number: 1018233-2021-02204
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other