MAUDE Adverse Event Report: TSCI BV DBA THE 37COMPANY MISTRAL-AIR PLUS (115V) BLOWER; SYSTEM, THERMAL REGULATING

Catalog Number MA1100-PM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Pain (1994); Complaint, Ill-Defined (2331)

Event Date 09/30/2015

Event Type  Injury  

Event Description

It was reported that the patient was in pacu-recovery complaining about heels being hot and painful.Pacu nurse observed the patients heels and reported redness.Wound care nurse was called and reported that the patient had redness on right heel, left heel unable to be assessed due to patient pain.Silvadene cream was applied to both heels.Wound care nurse reported redness and no blistering.Wound care nurse went back to check patient next day and reported no blistering.Patient was discharged the following day and sent home with silvadene cream.

Manufacturer Narrative

It was reported by the customer that a patient complained of red and painful heels after a surgical procedure where a mistral air unit was used on the patient's feet.There was no alleged malfunction of the unit, only that the patient complained of painful heels after the procedure.It was reported that mistral air blanket was plugged in at the foot end and wrapped around the patient's feet with the incorrect side of the blanket facing the patient.The nurse evaluated the patient and reported that there was no blistering on the heels.The patient was treated with silvadene cream and discharged the following day.The mistral air unit was not returned for evaluation.The device was not returned.

Event Description

It was reported that the patient was in pacu-recovery complaining about heels being hot and painful.Pacu nurse observed the patients heels and reported redness.Wound care nurse was called and reported that the patient had redness on right heel, left heel unable to be assessed due to patient pain.Silvadene cream was applied to both heels.Wound care nurse reported redness and no blistering.Wound care nurse went back to check patient next day and reported no blistering.Patient was discharged the following day and sent home with silvadene cream.

• Brand Name: MISTRAL-AIR PLUS (115V) BLOWER
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): TSCI BV DBA THE 37COMPANY; beeldschermweg 6f; ah amersfoort 03821 ; NL 03821
• Manufacturer (Section G): TSCI BV DBA THE 37COMPANY; beeldschermweg 6f; ah amersfoort 03821 ; NL 03821
• Manufacturer Contact: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 5192816
• MDR Text Key: 30019634
• Report Number: 3003312341-2015-00017
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MA1100-PM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1