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MAUDE Adverse Event Report: DIALYZER
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DIALYZER
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Lot Number
13PU01008 F160NR
Device Problem
Device Contamination with Chemical or Other Material (2944)
Patient Problem
No Patient Involvement (2645)
Event Date
03/26/2014
Event Type
Injury
Event Description
Inappropriate saline bag filing of questionable substance.
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Brand Name
DIALYZER
Type of Device
DIALYZER
MDR Report Key
3792891
MDR Text Key
4369036
Report Number
3792891
Device Sequence Number
4
Product Code
KDI
Reporter Country Code
US
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
User Facility
Reporter Occupation
Other
Type of Report
Initial
Report Date
03/26/2014
4
Devices were Involved in the Event:
1
2
3
4
1
Patient was Involved in the Event
Is this an Adverse Event Report?
Yes
Is this a Product Problem Report?
Yes
Device Operator
Other
Device Lot Number
13PU01008 F160NR
Is the Reporter a Health Professional?
Yes
Was the Report Sent to FDA?
Yes
Date Report Sent to FDA
03/27/2014
Distributor Facility Aware Date
03/26/2014
Event Location
Outpatient Treatment Facility
Initial Date Manufacturer Received
Not provided
Initial Date FDA Received
04/03/2014
Patient Sequence Number
1
Patient Age
80 YR
Patient Weight
87
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