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U.S. Department of Health and Human Services

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

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STRYKER MEDICAL-KALAMAZOO ALTRIX, DOMESTIC SYSTEM, THERMAL REGULATING Back to Search Results
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.
 
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Brand NameALTRIX, DOMESTIC
Type of DeviceSYSTEM, 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 Key8705527
MDR Text Key148262127
Report Number0001831750-2019-00593
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier07613327277555
UDI-Public07613327277555
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180834
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number8001000001
Device Catalogue Number8001000001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/17/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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