MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ALTRIX, DOMESTIC; SYSTEM, THERMAL REGULATING

Model Number 8001000001

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn, Thermal (2530)

Event Date 02/28/2019

Event Type  Injury  

Manufacturer Narrative

Customer did not make device available for evaluation.

Event Description

It was reported that a patient had burn marks on their legs that had the pattern of the blanket.The facility conducted an internal investigation and determined that the patient was burned due to liquid being left on the skin when the blanket was applied.The facility did not allege a malfunction of the device.The facility did not make the device available for evaluation by stryker.

Manufacturer Narrative

The facility informed stryker medical on (b)(6) 2019 that "there was no report of ulceration, any degree of burn, or blistering." they also noted that the patient was treated with a topical cream.Additionally, the facility did not notice any issue with the unit itself or any variations with flow and temperature.

Event Description

It was reported that a patient had burn marks on their legs that had the pattern of the blanket.The facility conducted an internal investigation and determined that the patient was burned due to liquid being left on the skin when the blanket was applied.The facility did not allege a malfunction of the device.The facility did not make the device available for evaluation by stryker.

• Brand Name: ALTRIX, DOMESTIC
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 8705527
• MDR Text Key: 148262127
• Report Number: 0001831750-2019-00593
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 07613327277555
• UDI-Public: 07613327277555
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180834
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/13/2019

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?: No
• Device Operator: No Information
• Device Model Number: 8001000001
• Device Catalogue Number: 8001000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/17/2019
• Supplement Dates Manufacturer Received: 05/23/2019
• Supplement Dates FDA Received: 08/13/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/17/2018
• 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