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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER CONSTAVAC; APPARATUS, AUTOTRANSFUSION
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STRYKER CONSTAVAC; APPARATUS, AUTOTRANSFUSION Back to Search Results
Catalog Number 0225-028-914
Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/04/2016
Event Type  malfunction  
Event Description
A patient underwent a total knee replacement.At the end of the operation, a constavac drain was placed in the surgical wound.When the time arrived to remove the drain, the rn experienced resistance.She asked another rn to evaluate the situation.The second rn also experience resistance, but was able to remove the drain.When examining the drain after removal, it was noted that there were only 4.5 holes rather than the expected 6.The surgeon was notified, and the patient had to return to the or to have the remaining portion of the drain removed from his knee.
 
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Brand Name
CONSTAVAC
Type of Device
APPARATUS, AUTOTRANSFUSION
Manufacturer (Section D)
STRYKER
4100 east milham ave.
kalamazoo MI 49001
MDR Report Key6043391
MDR Text Key57961900
Report Number6043391
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 User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2016
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Expiration Date05/01/2018
Device Catalogue Number0225-028-914
Device Lot Number16145012
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/29/2016
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer09/29/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO OTHER DEVICES WERE BEING USED ON THE PATIENT AT; NO OTHER THERAPIES
Patient Age59 YR
Patient Weight110
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