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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO LEG WRAP BLKT ASSY CLIK TITE; SYSTEM, THERMAL REGULATING
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STRYKER MEDICAL-KALAMAZOO LEG WRAP BLKT ASSY CLIK TITE; SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number 8001061540
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Tissue Damage (2104)
Event Date 05/01/2019
Event Type  Injury  
Event Description
It was alleged that a patient developed non-blanchable areas at the bottom of their legs.It was stated that the patient was seen by wound care but not treated and the family withdrew care and the patient passed away.It was reported that the patient was post cardiac arrest and on the targeted temperature management protocol.The event was not reported to have caused the patient death.
 
Manufacturer Narrative
It was reported by the user facility that a young male patient had been using the wrap during a targeted temperature management protocol following cardiac arrest and developed non-blanchable areas at the bottom of his legs.Allegedly the patient had required a woc consult, however, he was not treated.It was reported that the patient's family had withdrawn care and the patient ultimately passed away, however, it was not alleged to be attributed to the pressure injuries identified.No further information was provided regarding the treatment, therapy specifications, duration, patient condition, or other potential contributing factors.In response,attempts were made to gather further information regarding this alleged issue, however, the customer did not respond to these attempts.Device not returned.
 
Event Description
It was alleged that a patient developed non-blanchable areas at the bottom of their legs.It was stated that the patient was seen by wound care but not treated and the family withdrew care and the patient passed away.It was reported that the patient was post cardiac arrest and on the targeted temperature management protocol.The event was not reported to have caused the patient death.
 
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Brand Name
LEG WRAP BLKT ASSY CLIK TITE
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
brian thompson
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key8675278
MDR Text Key147217884
Report Number0001831750-2019-00583
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier07613327175073
UDI-Public07613327175073
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number8001061540
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received05/10/2019
Was Device Evaluated by Manufacturer? No
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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