• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO LEG WRAP BLKT ASSY CLIK TITE SYSTEM, THERMAL REGULATING

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER MEDICAL-KALAMAZOO LEG WRAP BLKT ASSY CLIK TITE SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number 8001061540
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)
Event Date 05/01/2019
Event Type  Injury  
Event Description
It was alleged that a patient was using the wrap and developed blisters on their leg. The customer alleges that the patient required wound care consult and was treated. It was reported that the patient was post cardiac arrest and on the targeted temperature management protocol.
 
Manufacturer Narrative
It was reported by the user facility that this complaint was documented from "a couple years ago. " it was reported that the patient had been using the wrap during a targeted temperature management protocol following cardiac arrest and developed blisters on her leg. Allegedly the patient had required a woc consult and was treated. 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 was using the wrap and developed blisters on their leg. The customer alleges that the patient required wound care consult and was treated. It was reported that the patient was post cardiac arrest and on the targeted temperature management protocol.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEG WRAP BLKT ASSY CLIK TITE
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 Key8675275
MDR Text Key147229158
Report Number0001831750-2019-00580
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
Type of Report Initial,Followup
Report Date 09/23/2019
1 Device was Involved in the Event
0 Patients were 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
Device Catalogue Number8001061540
Device Lot NumberUNKNOWN
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 Received05/10/2019
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

-
-