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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Superficial (First Degree) Burn (2685)
Event Date 03/05/2019
Event Type  malfunction  
Event Description
It was reported that the patient may have allegedly received a first degree burn during heating therapy. It was reported that the burn was treated with silvadene.
 
Manufacturer Narrative
It was alleged by the customer that the patient received burns to their gluteus. The burn was allegedly the same pattern as blanket. There was a sheet in between the patient and the warming blanket. The case lasted approximately 3 hours and the temp was set at 40°c. The burn was found when the patient arrived to the icu. It was reported that wound care was involved and that the burn was treated with silvadene. Device not available.
 
Event Description
It was reported that the patient may have allegedly received a first degree burn during heating therapy. It was reported that the burn was treated with silvadene.
 
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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
brian thompson
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key8473151
MDR Text Key140880156
Report Number0001831750-2019-00290
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
Report Date 06/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/02/2019
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 Received03/06/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/20/2017
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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