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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER STRYKER CBCII CONSTAVAC BLOOD CONSERVATION SYSTEM WITH QUICK DISCONNECT AND 0.18
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STRYKER STRYKER CBCII CONSTAVAC BLOOD CONSERVATION SYSTEM WITH QUICK DISCONNECT AND 0.18 Back to Search Results
Model Number 0225-028-926
Device Problem Entrapment of Device (1212)
Patient Problem No Code Available (3191)
Event Date 08/11/2017
Event Type  Injury  
Event Description
On (b)(6) 2017, patient had left total knee arthroplasty without difficulty.On (b)(6) 2017, patient in surgeon's office for routine post-op visit.No complaints voiced.Routine x-ray showed tip of drain lodged behind patella.Surgery was required, on (b)(6) 2017, to remove the drain.When arthroscopy was done on (b)(6) 2017, drain found to be pinched behind patella by the post on the tibial insert.Drain removed through the arthroscopy portal, and no complications noted.
 
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Brand Name
STRYKER CBCII CONSTAVAC BLOOD CONSERVATION SYSTEM WITH QUICK DISCONNECT AND 0.18
Type of Device
STRYKER CBCII CONSTAVAC BLOOD CONSERVATION SYSTEM WITH QUICK DISCONNECT AND 0.18
Manufacturer (Section D)
STRYKER
kalamazoo MI 49001
MDR Report Key6947459
MDR Text Key89382917
Report NumberMW5072738
Device Sequence Number1
Product Code CAC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/01/2019
Device Model Number0225-028-926
Device Lot Number17130012
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age64 YR
Patient Weight155
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