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MAUDE Adverse Event Report: CEREBRAL ANEURYSM CLIP
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CEREBRAL ANEURYSM CLIP
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Device Problem
Improper or Incorrect Procedure or Method (2017)
Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Type
No Answer Provided
Event Description
Mri scan done with aneurysm clips.Incorrect info provided by family member on screening form.Details unk - no adverse outcome.
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Brand Name
CEREBRAL ANEURYSM CLIP
Type of Device
ANEURYSM CLIP
MDR Report Key
7609598
MDR Text Key
111631524
Report Number
MW5077908
Device Sequence Number
1
Product Code
HCH
Combination Product (y/n)
N
Reporter Country Code
US
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
Voluntary
Reporter Occupation
Physician
Type of Report
Initial
Report Date
06/13/2018
1
Device was Involved in the Event
1
Patient was Involved in the Event
Date FDA Received
06/15/2018
Is this an Adverse Event Report?
No
Is this a Product Problem Report?
No
Device Operator
No Information
Was Device Available for Evaluation?
No
Is the Reporter a Health Professional?
Yes
Was Device Evaluated by Manufacturer?
No Information
Type of Device Usage
N
Patient Sequence Number
1
Patient Weight
57
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