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MAUDE Adverse Event Report: UNKNOWN; POWER PORT
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UNKNOWN; POWER PORT
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Device Problem
Difficult to Flush (1251)
Patient Problem
No Information (3190)
Event Date
01/21/2019
Event Type
Injury
Event Description
Pt had a non-functioning central venous access port and it was surgically explanted.Another port was surgically implanted in the right subclavian.
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Brand Name
UNKNOWN
Type of Device
POWER PORT
MDR Report Key
8288824
MDR Text Key
134703889
Report Number
8288824
Device Sequence Number
1
Product Code
LJT
Combination Product (y/n)
N
Reporter Country Code
US
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
User Facility
Reporter Occupation
Risk Manager
Type of Report
Initial
Report Date
01/22/2019
1
Device was Involved in the Event
1
Patient was Involved in the Event
Is this an Adverse Event Report?
No
Is this a Product Problem Report?
Yes
Device Operator
Health Professional
Was Device Available for Evaluation?
Yes
Is the Reporter a Health Professional?
Yes
Was the Report Sent to FDA?
Yes
Date Report Sent to FDA
01/22/2019
Distributor Facility Aware Date
01/21/2019
Event Location
Hospital
Initial Date Manufacturer Received
Not provided
Initial Date FDA Received
01/23/2019
Was Device Evaluated by Manufacturer?
No Information
Is This a Reprocessed and Reused Single-Use Device?
No
Type of Device Usage
N
Patient Sequence Number
1
Patient Outcome(s)
Hospitalization;
Patient Age
70 YR
Patient Weight
88
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