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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
Catalog Number 8001000001
Device Problem Insufficient Information (3190)
Patient Problem Tissue Damage (2104)
Event Date 05/30/2017
Event Type  malfunction  
Manufacturer Narrative
Supplemental submitted to include udi.
 
Event Description
It was alleged by the customer that the patient formed blisters during use of the device.
 
Event Description
It was alleged by the customer that the patient formed blisters during use of the device.
 
Manufacturer Narrative
This device was incorrectly reported, it was identified during the complaint investigation that this device did not cause or contribute to the alleged event.
 
Event Description
It was alleged by the customer that the patient formed blisters during use of the device.
 
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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 Key6673018
MDR Text Key108006480
Report Number0001831750-2017-00272
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152266
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received05/30/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/28/2017
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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