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MAUDE Adverse Event Report: BAXTER HEALTHCARE ACCESS
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BAXTER HEALTHCARE ACCESS
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Device Problem
Insufficient Information (3190)
Patient Problems
Abdominal Pain (1685); Abdominal Cramps (2543)
Event Date
05/20/2014
Event Type
Injury
Event Description
(b)(4).Severe abdominal cramps pain.
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Submit an Adverse Event Report
Brand Name
ACCESS
Manufacturer
(Section D)
BAXTER HEALTHCARE
MDR Report Key
5970093
MDR Text Key
55362374
Report Number
MW5064970
Device Sequence Number
1
Product Code
FKX
Combination Product (y/n)
N
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
Voluntary
Reporter Occupation
Patient
Type of Report
Initial
Report Date
06/29/2016
1
Device was Involved in the Event
1
Patient was Involved in the Event
Date FDA Received
09/22/2016
Is this an Adverse Event Report?
Yes
Is this a Product Problem Report?
No
Device Operator
No Information
Is the Reporter a Health Professional?
No
Type of Device Usage
N
Patient Sequence Number
1
Treatment
SOLUMEDROL MRI.
Patient Outcome(s)
Hospitalization; Life Threatening; Other;
Patient Age
45.000 YR
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