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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 Cooling (1130)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/31/2024
Event Type  malfunction  
Event Description
It was reported that, during therapy, the contact surface would not reach sufficient coolness and that this caused a delay in therapy for the patient.No other adverse consequences were alleged to have occurred as a result.
 
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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
brandon luckas
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key19192993
MDR Text Key341423173
Report Number0001831750-2024-00688
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier07613327277555
UDI-Public07613327277555
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 Nurse
Type of Report Initial
Report Date 04/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number8001000001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/31/2024
Initial Date FDA Received04/26/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/28/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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